Fulvestrant
Small molecule targets AR, ESR1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FULVESTRANT | — | 2021-05-12 | fda.gov ↗ |
| Label expansions (12) | US (FDA) | FASLODEX | — | 2003-12-24 – 2020-07-28 | fda.gov ↗ |
| Approved | EU (EMA) | Faslodex | — | 2004-03-09 | europa.eu ↗ |
| Approved | US (FDA) | FASLODEX | — | 2002-04-25 | fda.gov ↗ |
Trials 307 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 152 trials · 2 met primary | ||||||
| Phase 1 | NCT07867262 | Dec 2026 → Aug 2030 expected | breast cancer | Genentech, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07604272 | Oct 2026 → Jul 2028 expected | hernia, double inguinal | Northwestern University | Recruiting | No outcome recorded |
| Phase 1 | NCT07604571 | May 2026 → Jun 2032 expected | hormone receptor-positive breast cancer | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT07540572 | Mar 2026 → Mar 2030 expected | castration-resistant prostate carcinoma, colorectal carcinoma, estrogen-receptor positive breast cancer, non-small cell lung carcinoma | IDEAYA Biosciences | Recruiting | No outcome recorded |
| Phase 1 | NCT07226349 | Dec 2025 → Nov 2028 expected | neoplasm | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT07163481 | Oct 2025 → Dec 2026 expected | female breast carcinoma | Hunan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06995482 | Aug 2025 → May 2026 overdue | — | Kashiv BioSciences, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT07038369 | Jul 2025 → Aug 2028 expected | cervical carcinoma, endometrial carcinoma, estrogen-receptor positive breast cancer, fallopian tube cancer +3 | Atavistik Bio, Inc | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06784193 | Dec 2024 → May 2027 expected | castration-resistant prostate carcinoma, estrogen-receptor positive breast cancer, non-small cell lung carcinoma, progesterone-receptor positive breast cancer | Olema Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06663072 | Dec 2024 → Nov 2026 expected | pancreatic neuroendocrine tumor | University of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT06515470 | Jul 2024 → Sep 2027 expected | breast cancer | Biotheryx, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06253195 | Apr 2024 → Apr 2026 | hormone receptor-positive breast cancer, metastatic neoplasm | BeOne Medicines | Completed | No outcome recorded |
| Phase 1 | NCT06257264 | Mar 2024 → Aug 2026 overdue | endometrial cancer, gastric cancer, gastroesophageal cancer, hormone receptor-positive breast cancer +5 | BeiGene | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05905341 | Jan 2024 → Apr 2026 | breast cancer, endometrial cancer, liposarcoma, non-small cell lung carcinoma +1 | Pfizer | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT06120283 | Dec 2023 → Dec 2029 expected | hormone receptor-positive breast cancer | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT05870579 | Nov 2023 → Dec 2026 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05759949 | Mar 2023 → Mar 2025 | PIK3CA-related overgrowth spectrum, hormone receptor-positive breast cancer | Relay Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06074757 | Mar → Sep 2023 | breast cancer | Kashiv BioSciences, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05238922 | Jul 2022 → Jul 2027 expected | cancer | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05252416 | Apr 2022 → Jul 2025 | carcinosarcoma, endometrial cancer, esophageal adenocarcinoma, gastric cancer +2 | Blueprint Medicines Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT05504213 | Jan 2022 → Jul 2023 | breast cancer | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04316169 | Oct 2021 → Jan 2027 | female breast carcinoma | Medical College of Wisconsin | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04556773 | Dec 2020 → Aug 2023 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04483505 | Nov 2020 → Apr 2023 | hormone receptor-positive breast cancer | CRIS Cancer Foundation | Completed | No outcome recorded |
| Phase 1 | NCT03685331 | Oct 2020 → Aug 2025 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, breast cancer | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT03554044 | Feb 2020 → Dec 2023 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, invasive breast carcinoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT02964507 | Sep 2019 → Sep 2020 | neoplasm | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1 | NCT06047184 | Jul 2019 → Oct 2023 | female breast carcinoma | BeBetter Med Inc | Unknown | No outcome recorded |
| Phase 1 | NCT03959891 | May 2019 → Dec 2022 overdue | breast cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03854903 | Apr 2019 → Nov 2023 | hormone receptor-positive breast cancer | Georgetown University | Completed | No outcome recorded |
| Phase 1 | NCT03767335 | Nov 2018 → Feb 2024 | breast cancer | Menarini Group | Completed | No outcome recorded |
| Phase 1 | NCT03294694 | Nov 2017 → Oct 2020 | hormone receptor-positive breast cancer, malignant epithelial tumor of ovary | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03308201 | Oct 2017 → Jun 2022 | breast cancer | Tianjin Hemay Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03238196 | Aug 2017 → Apr 2021 | breast cancer | Vanderbilt-Ingram Cancer Center | Completed | Met primary |
| Phase 1 | NCT03099174 | May 2017 → May 2023 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03006172 | Dec 2016 → Dec 2026 expected | breast cancer | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02936206 | Oct 2016 → May 2020 | breast cancer | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02761694 | Jun 2016 → Mar 2021 | cancer | ArQule, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02684032 | Jun 2016 → Jan 2022 | breast cancer | Celcuity Inc | Completed | No outcome recorded |
| Phase 1 | NCT02640755 | Jan → Dec 2016 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02626507 | Jan 2016 → Feb 2022 | breast cancer | Hoffman Oncology | Unknown | No outcome recorded |
| Phase 1 | NCT02384746 | Jun 2015 → Apr 2018 | breast cancer | Dartmouth-Hitchcock Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02333370 | Feb 2015 → Sep 2022 | hormone receptor-positive breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02088684 | May 2014 → Apr 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02057133 | Mar 2014 → Mar 2021 overdue | breast neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02026973 | Mar 2014 → Nov 2015 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT01344031 | Apr → Jul 2011 | estrogen-receptor positive breast cancer, invasive breast carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01219699 | Oct 2010 → Feb 2015 | estrogen-receptor positive breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01394016 | Dec 2009 → May 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01004419 | Nov 2009 → Nov 2010 | non-small cell lung carcinoma | University of Wisconsin, Madison | Withdrawn | No outcome recorded |
| Phase 1 | NCT01186796 | Jun 2009 → Jun 2013 | — | Mayo Clinic | Completed | Met primary |
| Phase 1 | NCT00328120 | Apr 2004 → Apr 2006 | female breast carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1/240 trials · 1 missed | ||||||
| Phase 1/2 | NCT07861932 | Oct 2026 → Sep 2028 expected | breast neoplasm | KymaThera, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07811232 | Sep 2026 → Sep 2030 expected | breast neoplasm, endometrium neoplasm, soft tissue sarcoma | Advenchen Pharmaceuticals, LLC. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07570966 | Jun 2026 → Aug 2031 | castration-resistant prostate carcinoma, hormone receptor-positive breast cancer | Novartis Pharmaceuticals | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT07389733 | Mar 2026 → Dec 2028 expected | breast cancer | Shandong Suncadia Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07235176 | Jan 2026 → Nov 2028 expected | Her2-receptor negative breast cancer | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07288359 | Dec 2025 → May 2031 expected | castration-resistant prostate carcinoma, hormone receptor-positive breast cancer | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06998407 | Aug 2025 → Aug 2028 expected | hormone receptor-positive breast cancer | Avenzo Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06851442 | May → Nov 2025 | breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT06726148 | Apr 2025 → Sep 2028 expected | hormone receptor-positive breast cancer, small cell lung carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06788197 | Mar 2025 → Mar 2028 expected | breast cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06555068 | Aug 2024 → Dec 2027 expected | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05986071 | May 2024 → Apr 2027 expected | breast cancer | Institut Paoli-Calmettes | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06208410 | Jan 2024 → Feb 2027 expected | neoplasm | Risen (Suzhou) Pharma Tech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06110793 | Dec 2023 → Nov 2027 expected | breast cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05867251 | Aug 2023 → Jan 2028 expected | endometrial cancer, fallopian tube cancer, hormone receptor-positive breast cancer, malignant epithelial tumor of ovary +2 | Avenzo Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06202261 | Apr 2023 → Dec 2026 expected | breast carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05792410 | Apr 2023 → Feb 2024 | Her2-receptor negative breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05608252 | Feb 2023 → Dec 2027 expected | hormone receptor-positive breast cancer | Adrienne G. Waks | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05574881 | Sep 2022 → Jan 2025 | breast cancer | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05191004 | Sep 2022 → Jun 2025 | breast carcinoma | Nuvation Bio Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05251714 | May 2022 → Aug 2026 overdue | breast cancer | Treadwell Therapeutics, Inc | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05319873 | Apr 2022 → Apr 2027 expected | HER2 positive breast carcinoma, invasive breast carcinoma | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05262400 | Mar 2022 → Feb 2027 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05176080 | Dec 2021 → Jul 2024 | breast cancer | Henan Cancer Hospital | Terminated | Mixed |
| Phase 1/2 | NCT04282031 | Jun 2020 → Dec 2024 overdue | hormone receptor-positive breast cancer | Beta Pharma (Suzhou) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04092673 | Oct 2019 → Dec 2024 | cancer | Effector Therapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT03772353 | May 2019 → Jun 2023 | breast cancer | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03803761 | Feb 2019 → Feb 2022 | female breast carcinoma, invasive breast carcinoma, metastatic malignant neoplasm in the brain | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03169777 | Aug 2018 → Jan 2019 | colorectal cancer | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03481998 | Mar 2018 → Jul 2022 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT03519178 | Mar 2018 → Apr 2023 | breast cancer | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03169738 | Feb 2018 → Jan 2019 | non-small cell lung carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03280563 | Dec 2017 → Sep 2024 | breast neoplasm | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT03197584 | Dec 2017 → Feb 2019 | ovarian carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03197571 | Dec 2017 → Jan 2019 | urothelial carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03169764 | Dec 2017 → Jan 2019 | head and neck squamous cell carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03344536 | Nov 2017 → Aug 2021 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02657343 | Mar 2016 → Aug 2020 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02345772 | Jul 2014 → Nov 2015 | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer | Western Regional Medical Center | Terminated | No outcome recorded |
| Phase 2160 trials · 8 met primary · 11 missed | ||||||
| Phase 2 | NCT07748208 | Oct 2026 → Jun 2029 expected | breast cancer, type 2 diabetes mellitus | Hoffmann-La Roche | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07857226 | Sep 2026 → Jun 2028 expected | breast cancer | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07340619 | May 2026 → Nov 2028 expected | metastatic melanoma | UNICANCER | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07227233 | Mar 2026 → Dec 2027 expected | breast cancer | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 2 | NCT07498478 | Mar 2026 → Jun 2027 expected | breast cancer | TransThera Sciences (Nanjing), Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07235618 | Jan 2026 → Jan 2028 expected | breast cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07333937 | Dec 2025 → Nov 2027 expected | breast cancer | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07330544 | Nov 2025 → Nov 2027 expected | breast cancer | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07179939 | Sep 2025 → Dec 2030 expected | HER2 positive breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07037199 | Aug 2025 → Jun 2028 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Show all 160 trials opens the full record — a long page | ||||||
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT06506955 | Oct 2024 → Apr 2027 expected | metastatic neoplasm | Taiho Oncology, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 2/3 | NCT04753177 | Jan 2021 → Jan 2023 | — | Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary | Unknown | No outcome recorded |
| Phase 2/3 | NCT02692755 | Sep 2016 → Dec 2019 | hormone receptor-positive breast cancer | Georgetown University | Completed | No outcome recorded |
| Phase 2/3 | NCT02116803 | May 2014 → Nov 2016 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 339 trials · 5 met primary · 7 missed | ||||||
| Phase 3 | NCT07802626 | Oct 2026 → Oct 2034 expected | hormone receptor-positive breast cancer | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07683754 | Sep 2026 → Jul 2030 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Daiichi Sankyo | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07062965 | Aug 2025 → Jul 2027 expected | breast cancer | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT06757634 | Jul 2025 → Mar 2029 expected | breast cancer | Celcuity Inc | Recruiting | No outcome recorded |
| Phase 3 | NCT06764186 | Jan 2025 → Dec 2027 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06635447 | Sep 2024 → Oct 2026 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06380751 | Aug 2024 → Dec 2029 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT05646862 | Jun 2023 → Nov 2026 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05501886 | Dec 2022 → Jun 2026 overdue | breast cancer | Celcuity Inc | Active not recruiting | Met primary |
| Phase 3 | NCT04851613 | Feb 2022 → Oct 2026 expected | breast cancer | Laekna Limited | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04975308 | Oct 2021 → Jun 2024 overdue | breast cancer, metastatic malignant neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05063786 | Sep 2021 → Jun 2026 overdue | breast cancer | Spanish Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04862663 | May 2021 → Nov 2027 expected | Her2-receptor negative breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT04646759 | Oct 2020 → Dec 2028 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT04337658 | Jul 2020 → Apr 2024 | HER2 positive breast carcinoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 3 | NCT04158362 | Jun 2020 → Apr 2025 overdue | metastatic malignant neoplasm | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03462251 | May 2018 → Nov 2021 | hormone receptor-positive breast cancer | iOMEDICO AG | Completed | No outcome recorded |
| Phase 3 | NCT04263298 | May 2018 → May 2025 overdue | breast cancer | Herui Yao | Recruiting | Met primary |
| Phase 3 | NCT03439046 | Feb 2018 → Dec 2023 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT03079011 | Mar 2017 → Apr 2021 | breast cancer | UNICANCER | Completed | Met primary |
| Phase 3 | NCT02404051 | Dec 2015 → Jan 2018 | hormone receptor-positive breast cancer, secondary malignant neoplasm | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 3 | NCT02383030 | Nov 2015 → Sep 2017 | breast cancer | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 3 | NCT02344472 | Sep 2015 → Jan 2025 | breast cancer | University of Ulm | Unknown | No outcome recorded |
| Phase 3 | NCT02137837 | May 2014 → Dec 2019 | breast cancer | SWOG Cancer Research Network | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02028507 | Mar 2014 → Jan 2019 | breast cancer | Spanish Breast Cancer Research Group | Completed | Missed primary |
| Phase 3 | NCT01602380 | Oct 2012 → Apr 2016 | hormone receptor-positive breast cancer | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01300351 | Mar 2011 → Mar 2014 | breast cancer | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00944918 | Dec 2008 → Jun 2011 | — | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00545077 | Nov 2007 → Dec 2013 | breast cancer | Spanish Breast Cancer Research Group | Completed | Missed primary |
| Phase 3 | NCT00543127 | Nov 2007 → Jul 2016 | breast cancer | Spanish Breast Cancer Research Group | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT00390455 | Sep 2006 → Jul 2014 | HER2 positive breast carcinoma, Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 3 | NCT00327769 | Nov 2005 → Sep 2007 | female breast carcinoma | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00099437 | Feb 2005 → Feb 2009 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00075764 | Apr 2004 → Dec 2012 | breast cancer | SWOG Cancer Research Network | Completed | Met primary |
| Phase 3 | NCT00256698 | Jan 2004 → Apr 2009 | breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00065325 | Aug 2003 → Jun 2006 | breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00010153 | Nov 2000 → Oct 2001 | breast cancer | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00241449 | Nov 1998 → Mar 2007 | breast cancer, metastatic neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00635713 | May 1997 → Sep 2004 | female breast carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT05631795 | Aug 2022 → Jun 2025 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT05362760 | Apr 2022 → Apr 2029 expected | hormone receptor-positive breast cancer | University of Ulm | Recruiting | No outcome recorded |
| Phase 4 | NCT05191914 | Feb → Jul 2022 | breast cancer | Liaoning Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 4 | NCT04031885 | Aug 2019 → Aug 2020 | breast cancer | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03591549 | Aug 2018 → Aug 2021 | breast cancer | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT03355157 | Mar 2018 → Aug 2024 | breast cancer | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 4 | NCT02447328 | May 2015 → May 2016 | breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06856200 | Feb → Oct 2025 overdue | Her2-receptor negative breast cancer, hormone-resistant breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| — | NCT05295043 | Dec 2022 → Jan 2024 | Her2-receptor negative breast cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| — | NCT05047848 | Aug 2021 → Jun 2022 | female breast carcinoma | Liaoning Cancer Hospital & Institute | Unknown | No outcome recorded |
| — | NCT00126464 | Nov 2004 → ? | breast cancer | Cedars-Sinai Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy210 trials | ||||||
| Phase 0 | NCT02913430 Comparator | Apr 2018 → Apr 2022 | breast cancer | Shannon Puhalla | Completed | No outcome recorded |
| Phase 1 | NCT07358377 Background | May 2026 → Apr 2027 expected | breast cancer | Atridia Pty Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT07480681 Background | Mar 2026 → Mar 2028 expected | — | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07408089 Background | Feb 2026 → Feb 2029 expected | breast cancer | Boundless Bio, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07366632 Comparator | Jan → May 2026 overdue | — | Shanghai Best-Link Bioscience, LLC | Not yet recruiting | No outcome recorded |
| Show all 210 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 106
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Celcuity Inc | Results Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer celcuity.com ↗
Gedatolisib plus fulvestrant and palbociclib (the “gedatolisib-triplet”) reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). |
| 2026-05-18 | Biotheryx, Inc. | Results Biotheryx Announces Data from its Phase 1 Dose Escalation Study of BTX-9341, a First-in-Class, Potent and Selective CDK4/6 Degrader, for the Treatment of Advanced/Metastatic HR+/HER2- Breast Cancer biotheryx.com ↗
Importantly, BTX-9341 was well tolerated, with participants on treatment for over 12 cycles (48 weeks), including on monotherapy and in combination with fulvestrant. |
| 2026-05-06 | Totus Medicines | Results Totus Medicines Presents Early Phase 1b Clinical Data Demonstrating 100% Disease Control Rate and Class-Leading Safety for TOS-358 + Fulvestrant Doublet Therapy in HR+/HER2- Breast Cancer at ESMO Breast Cancer Annual Congress 2026 totusmedicines.com ↗
First presentation of combination data demonstrates 100% disease control rate and 89% clinical benefit rate in women, including PAM-experienced patients, with median time on therapy exceeding 24 weeks |
| 2026-05-06 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 库莫西利一线治疗乳腺癌获批上市!中国生物制药推动CDK治疗迈入新阶段 cttq.com ↗
5月6日,国家药品监督管理局(NMPA)官网显示,中国生物制药(1177.HK)核心企业正大天晴自主研发的库莫西利胶囊(赛坦欣®)第2个适应症获批上市,联合氟维司群用于激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的局部晚期或转移性乳腺癌患者的初始内分泌治疗。 |
| 2026-05-01 | Celcuity Inc | Results Celcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort celcuity.com ↗
The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib (the “gedatolisib triplet”) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (“PFS”) compared to alpelisib, a PI3Kα inhibitor, and fulvestrant. |
| 2026-04-27 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Clinical Data for Zovegalisib plus Atirmociclib Triplet Combination Supportive of Further Development in Frontline Metastatic Breast Cancer relaytx.com ↗ |
| 2026-04-17 | Olema Pharmaceuticals, Inc. | Results Olema Oncology Announces Preclinical Data for Palazestrant and OP-3136 at the 2026 AACR Annual Meeting olema.com ↗
Combining OP-3136 with palazestrant or fulvestrant suppresses expression of genes associated with MTORC1 signaling, indicating that targeting KAT6 and ER-alpha can suppress mechanisms of acquired resistance. |
| 2026-04-15 | Laekna Limited | Results Positive Topline Results | Laekna’s Phase III Clinical Trial of LAE002 (afuresertib) for Breast Cancer Met Primary Endpoint
Positive Topline Results | Laekna’s Phase III Clinical Trial of LAE002 (afuresertib) for Breast Cancer Met Primary Endpoint laekna.com ↗
The study met its primary endpoint, LAE002 (afuresertib) plus fulvestrant combination demonstrated a highly statistically significant and clinically meaningful improvement of PFS versus control. |
| 2026-03-16 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Data from Zovegalisib + Fulvestrant at the Phase 3 Dose of 400mg BID Fed at ESMO Targeted Anticancer Therapies Congress 2026 relaytx.com ↗
“As supported by the data presented, the 400mg BID fed regimen maintains robust efficacy with a safety profile consistent with mutant-selective PI3Kα inhibition,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. |
| 2026-03-09 | Celcuity Inc | Results Celcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer in Journal of Clinical Oncology celcuity.com ↗
The publication is titled “VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer.” |
| 2026-02-12 | Laekna Limited | Results Nature Communications, February Issue | Afuresertib Plus Fulvestrant Was Well Tolerated and Had Promising Anti-Tumor Activities Against Pretreated, Advanced HR-positive, Her2-negative Breast Cancer
Nature Communications, February Issue | Afuresertib Plus Fulvestrant Was Well Tolerated and Had Promising Anti-Tumor Activities Against Pretreated, Advanced HR-positive, Her2-negative Breast Cancer laekna.com ↗
The findings indicate that this combination regimen was well-tolerated and had promising antitumor activities against pretreated, advanced HR-positive, HER2-negative breast cancer. |
| 2026-02-03 | Relay Therapeutics, Inc. | Regulatory Relay Therapeutics Announces Zovegalisib Granted Breakthrough Therapy Designation by U.S. FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer relaytx.com ↗
This Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date. |
| 2025-12-12 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Efficacy Subset Analysis of Zovegalisib (RLY-2608) + Fulvestrant in Breast Cancer Patients Pre-Treated with SERD or with ESR1 Mutations at SABCS 2025 relaytx.com ↗ |
| 2025-12-11 | Avenzo Therapeutics, Inc. | Results Avenzo Therapeutics Presents Initial Results from the Phase 1/2 Study of AVZO-021, a Potential Best-in-Class CDK2 Inhibitor, at the 2025 San Antonio Breast Cancer Symposium avenzotx.com ↗
Avenzo Therapeutics Presents Initial Results from the Phase 1/2 Study of AVZO-021, a Potential Best-in-Class CDK2 Inhibitor, at the 2025 San Antonio Breast Cancer Symposium |
| 2025-12-10 | Carrick Therapeutics Limited | Results Carrick Therapeutics Announces Positive Results from Phase 2 Randomized Trial of Samuraciclib in Combination with Fulvestrant in Patients with Hormone Receptor Positive, HER2 Negative Advanced Breast Cancer carricktherapeutics.com ↗
These Phase 2 trial results show that samuraciclib in combination with fulvestrant provided a very notable and clinically meaningful benefit in a broad patient population with HR positive, HER2 negative metastatic breast cancer whose disease progressed following treatment with a CDK4/6 inhibitor. |
| 2025-11-25 | Novartis Pharmaceuticals | Results Novartis data underscore pioneering scientific innovation in hematology and oncology at ASH and SABCS novartis.com ↗
Progression-free survival (PFS) and overall survival (OS) results from the phase 3 MONALEESA-3 trial of postmenopausal patients with hormone receptor–positive (HR+)/HER2-negative (HER2−) advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL): A subgroup analysis of patients with invasive lobular carcinoma (ILC) |
| 2025-10-30 | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Results BBOT Announces Poster Presentations at the San Antonio Breast Cancer Symposium (SABCS) bbotx.com ↗
BBO-10203, a first-in-class breaker of the RAS:PI3Kα interaction, inhibits tumor growth alone and in combination with fulvestrant or ribociclib in breast cancer models without inducing hyperglycemia |
| 2025-10-20 | Arvinas Inc. | Results Patient-Reported Outcomes from VERITAC-2 Clinical Trial Support Clinical Benefit of Vepdegestrant in Patients with ESR1-Mutated, ER+/HER2- Advanced or Metastatic Breast Cancer Previously Treated with Endocrine-Based Therapy arvinas.com ↗
In the VERITAC-2 clinical trial, patients with ESR1-mutated disease treated with vepdegestrant reported a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains compared to those who received fulvestrant. |
| 2025-06-02 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Updated Data for RLY-2608 + Fulvestrant Further Demonstrating Clinically Meaningful Progression Free Survival at ASCO 2025 relaytx.com ↗
They show a median progression free survival (PFS) of 11.0 months in second line (2L) patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer who received RLY-2608 600mg twice daily (BID) + fulvestrant. |
| 2025-05-31 | Hoffmann-La Roche | Results New data show Roche’s Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer roche.com ↗
These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. |
| 2025-05-31 | Genentech, Inc. | Results New Data Show Genentech’s Itovebi Significantly Extended Survival in a Certain Type of HR-Positive Advanced Breast Cancer gene.com ↗
These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. |
| 2025-05-23 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer roche.com ↗
Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubled progression-free survival in the first-line setting1 |
| 2025-05-15 | Carrick Therapeutics Limited | Results Carrick Therapeutics Announces New Clinical Data Supporting Biomarker-driven Patient Selection for Samuraciclib (CDK7i) in Combination with SERDs in Hormone Receptor Positive Advanced Breast Cancer carricktherapeutics.com ↗
The analysis indicated that study participants with no evidence of a deleterious mutation in the TP53 gene in circulating tumor DNA at baseline or separately, without liver metastases at baseline, experienced extended durations of progression-free survival. |
| 2025-03-11 | Pfizer | Results Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial pfizer.com ↗
The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to fulvestrant. |
| 2025-01-28 | Hoffmann-La Roche | Results Roche’s Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer roche.com ↗
The study met its key secondary endpoint, showing a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen compared with palbociclib and fulvestrant alone. |
| 2025-01-27 | Genentech, Inc. | Results Genentech’s Itovebi Demonstrated Statistically Significant and Clinically Meaningful Overall Survival Benefit in a Certain Type of HR-Positive Advanced Breast Cancer gene.com ↗
The study met its key secondary endpoint, showing a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen compared with palbociclib and fulvestrant alone. |
| 2024-12-11 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Updated Interim Data for RLY-2608 + Fulvestrant Demonstrating Continued Maturation of Clinically Meaningful Progression Free Survival relaytx.com ↗
New interim data show 11.4-month median PFS in 2L patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D |
| 2024-10-31 | Hoffmann-La Roche | Results New England Journal of Medicine publishes landmark phase III results for Roche’s Itovebi, showing more than doubling of progression-free survival in certain type of HR-positive advanced breast cancer roche.com ↗
ItovebiTM (inavolisib)-based regimen demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study1 |
| 2024-10-30 | Genentech, Inc. | Results New England Journal of Medicine Publishes Landmark Phase III Results for Genentech’s Itovebi, Showing More Than Doubling of Progression-Free Survival in Certain Type of HR-Positive Advanced Breast Cancer gene.com ↗
ItovebiTM (inavolisib)-based regimen demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study |
| 2024-10-11 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗ |
| 2024-09-19 | Laekna Limited | Results Laekna Announces Robust Phase 1b data of LAE002 (afuresertib) for treatment of HR+/ HER2- Breast Cancer at ESMO Congress 2024
Laekna Announces Robust Phase 1b data of LAE002 (afuresertib) for treatment of HR+/ HER2- Breast Cancer at ESMO Congress 2024 laekna.com ↗
Confirmed ORR was 33.3%, CBR was 66.7%, and the median PFS was 7.3 months |
| 2024-09-09 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Positive Interim Data for RLY-2608 Demonstrating Clinically Meaningful Progression Free Survival relaytx.com ↗
The data showed that despite heavy pre-treatment, patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer who received RLY-2608 600mg BID + fulvestrant demonstrated clinically meaningful progression free survival (PFS). |
| 2024-07-24 | Laekna Limited | Results Laekna Announces Significant Progress on Clinical Developments
Laekna Announces Significant Progress on Clinical Developments laekna.com ↗
Results of the Phase Ib study in all 31 patients and in a subgroup with PIK3CA/AKT1/PTEN alterations from U.S. and China have demonstrated promising anti-cancer efficacy with a well-tolerated safety profile. |
| 2024-07-02 | Laekna Limited | Results Investigator Meeting of Laekna AFFIRM-205(a phase III clinical study of breast cancer) Held in Beijing
Investigator Meeting of Laekna AFFIRM-205(a phase III clinical study of breast cancer) Held in Beijing laekna.com ↗
As shown in the results of our phase Ib study, the median PFS of afuresertib plus fulvestrant was 7.3 months, which significantly improved from the PFS data of 3-4 months for fulvestrant monotherapy2. |
| 2024-06-20 | AstraZeneca | Regulatory Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer astrazeneca.com ↗
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. |
| 2024-06-02 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Presentation of Findings from a Phase II Study of Alisertib in Endocrine-Resistant Metastatic Breast Cancer (TBCRC 041) pumabiotechnology.com ↗ |
| 2024-05-23 | Blueprint Medicines Corporation | Results Blueprint Medicines to Present the First Promising and Most Advanced Clinical Data for a CDK2 Inhibitor in Combination with an Approved CDK4/6 Inhibitor in HR+/HER2- Breast Cancer at the 2024 ASCO Annual Meeting blueprintmedicines.com ↗ |
| 2024-04-29 | AstraZeneca | Regulatory Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2024-03-27 | Chugai Pharmaceutical | Regulatory Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile to Be Used as a Companion Diagnostic for the AKT Inhibitor, Capivasertib for Advanced HR-positive, HER2-negative Breast Cancer with PIK3CA, AKT1 or PTEN Alterations chugai-pharm.co.jp ↗
which was approved by the MHLW on March 26, 2024. |
| 2024-03-27 | AstraZeneca | Regulatory Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer astrazeneca.com ↗
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in Japan for the treatment of adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone receptor (HR)-positive, HER2-negative breast cancer following progression after treatment with endocrine therapy. |
| 2023-12-11 | Laekna Limited | Results 2023 SABCS│Laekna Reports Afuresertib Phase Ib Breast Cancer Study Results
2023 SABCS│Laekna Reports Afuresertib Phase Ib Breast Cancer Study Results laekna.com ↗
Among the total patient population, the confirmed ORR was 30% (95% CI, 11.9, 54.3), the median PFS was 7.3 months (95% CI, 3.7, NE). |
| 2023-12-08 | Hoffmann-La Roche | Results Roche’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
The inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001). |
| 2023-12-08 | Genentech, Inc. | Results Genentech’s Inavolisib Combination Reduces the Risk of Disease Progression by 57% in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation gene.com ↗
The inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001). |
| 2023-12-08 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Presents Updated Phase 2a Data at SABCS 2023 Showcasing Potential of Zanidatamab in HER2+/HR+ Metastatic Breast Cancer jazzpharma.com ↗
First presentation of progression-free survival (PFS) primary endpoint data show zanidatamab plus palbociclib and fulvestrant demonstrated a PFS of 67% at 6 months and a median PFS of 12 months in patients with heavily pre-treated HER2+/HR+ metastatic breast cancer (mBC) |
| 2023-12-05 | Hoffmann-La Roche | Results Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone. |
| 2023-12-04 | Genentech, Inc. | Results Genentech Announces Positive Phase III Results for Inavolisib Combination in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation gene.com ↗
Phase III (INAVO120) results shows that inavolisib in combination with palbociclib and fulvestrant significantly improved progression-free survival in the first-line setting |
| 2023-11-20 | Astex Pharmaceuticals, Inc. | Regulatory Third Success from Astex Drug Discovery Pharma Collaboration and Licence Agreements as AstraZeneca Receives US Marketing Approval for Cancer Drug Truqap (capivasertib) astx.com ↗
AstraZeneca’s Truqap TM (capivasertib) in combination with Faslodex ® (fulvestrant) receives US FDA marketing approval for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). |
| 2023-11-17 | AstraZeneca | Regulatory Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer astrazeneca.com ↗
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). |
| 2023-09-19 | SynDevRx, Inc. | Results Amelia-1 Clinical Trial Fully Open To Recruitment, 1st Patient Data on Combination Study with PI3K Inhibitor and SERD syndevrx.com ↗
Further, ctDNA data shows no evidence of residual PIK3CA mutation in blood after 6 weeks of treatment. |
| 2023-08-08 | Relay Therapeutics, Inc. | Results Relay Therapeutics Reports Second Quarter 2023 Financial Results and Corporate Highlights relaytx.com ↗
Updated RLY-2608 600mg BID + fulvestrant data: interim clinical benefit rate of 86% (6 of 7 evaluable patients) & 1 of 5 patients with measurable disease achieved a partial response |
| 2023-06-12 | AstraZeneca | Regulatory Capivasertib in combination with Faslodex granted Priority Review in the US for patients with advanced HR-positive breast cancer astrazeneca.com ↗ |
| 2023-06-05 | Betta Pharmaceuticals Co., Ltd. | Results ASCO 2023 | 贝达药业BPI-16350确认的ORR高达60.5%!有望成为HR+/HER2-晚期转移性乳腺癌患者新的治疗选择 bettapharma.com ↗
在B阶段,46例患者中,43例至少进行过一次疗效评估,DCR为97.7%(42/43),确认的ORR高达60.5%(26/43),中位PFS尚未达到。 |
| 2023-03-14 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Publication of Phase II Clinical Trial of Alisertib in JAMA Oncology pumabiotechnology.com ↗
The efficacy results from the trial showed that for the 46 evaluable patients in the alisertib alone arm of the trial nine partial responses were seen, resulting in an overall response rate of 19.6%. |
| 2022-12-09 | Treadwell Therapeutics, Inc | Results Treadwell Therapeutics Announces A Presentation at the 2022 SABCS Annual Meeting Featuring a Clinical Trial Update on CFI-402257, a Best-in-Class TTK inhibitor treadwelltx.com ↗ |
| 2022-12-08 | AstraZeneca | Results Capivasertib plus Faslodex reduced the risk of disease progression or death by 40% versus Faslodex in advanced HR-positive breast cancer astrazeneca.com ↗
In the AKT pathway biomarker-altered population, capivasertib plus Faslodex reduced the risk of disease progression or death by 50% versus placebo plus Faslodex (HR of 0.50, 95% CI 0.38-0.65; p=<0.001; median 7.3 versus 3.1 months). |
| 2022-12-08 | AstraZeneca | Results Camizestrant significantly delayed disease progression in advanced ER-positive breast cancer, adding at least 3.5 months benefit versus Faslodex astrazeneca.com ↗ |
| 2022-12-01 | Alembic Pharmaceuticals Ltd. | Regulatory 26th December, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals receives USFDA Final Approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-Dose Prefilled Syringe. |
| 2022-10-26 | AstraZeneca | Results Capivasertib plus Faslodex significantly improved progression-free survival vs. Faslodex in CAPItello-291 Phase III trial in advanced HR-positive breast cancer astrazeneca.com ↗
The trial met both primary endpoints, improving PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumours had qualifying alterations in the PIK3CA, AKT1 or PTEN genes. |
| 2022-06-06 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Outcomes from the Metastatic Breast Cancer Cohort of the SUMMIT Trial at the ASCO 2022 Annual Meeting pumabiotechnology.com ↗ |
| 2022-06-03 | Novartis Pharmaceuticals | Results New Novartis data show Piqray® effectiveness across key biomarkers in patients with HR+/HER2- metastatic breast cancer novartis.com ↗ |
| 2022-05-04 | Novartis Pharmaceuticals | Results New Novartis data demonstrate only Kisqali® offers more life in the first-line setting for postmenopausal HR+/HER2- advanced breast cancer patients novartis.com ↗
Novartis today announced updated median overall survival (OS) results for Kisqali ® (ribociclib) in combination with fulvestrant in the first-line subgroup of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. |
| 2021-12-10 | Novartis Pharmaceuticals | Results Novartis data highlight efficacy of Piqray® in HR+/HER2- metastatic breast cancer with a PIK3CA driver mutation immediately post-CDK4/6i novartis.com ↗
New data underscore efficacy of Piqray, even in those patients with a short treatment duration on prior CDK4/6i or with ESR1 mutations, biomarkers of endocrine resistance |
| 2021-12-10 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Updates from the SUMMIT Trial at the 2021 SABCS Annual Meeting ◼ Neratinib in combination with fulvestrant and trastuzumab offers promising results for patients with hormone receptor-positive, HER2-mutated metastatic breast cancer with prior exposure to CDK4/6 inhibitors ◼ Neratinib in combination with trastuzumab results in strong activity in patients with triple negative metastatic breast cancer with a HER2 mutation pumabiotechnology.com ↗ |
| 2021-12-09 | Carrick Therapeutics Limited | Results Carrick Therapeutics Presents Encouraging Clinical Data for Samuraciclib (CT7001) at the 2021 San Antonio Breast Cancer Symposium carricktherapeutics.com ↗
Samuraciclib in combination with fulvestrant in the post CDK4/6 setting has demonstrated a median mPFS of 32 weeks. |
| 2021-09-16 | Carrick Therapeutics Limited | Results Carrick Therapeutics Presents Encouraging Initial Efficacy for Samuraciclib (CT-7001) in Combination with Fulvestrant in Advanced HR+, HER2- Breast Cancer Patients at ESMO Congress 2021 carricktherapeutics.com ↗
Data presented from a Phase 2a study of samuraciclib in combination with fulvestrant in women with hormone receptor positive (HR+), HER2- advanced breast cancer (BC) previously treated with a CDK4/6 inhibitor (abstract: 1346 (265P)) demonstrated clinical activity and tolerability that supports further clinical development of the combination. |
| 2021-08-16 | Carrick Therapeutics Limited | Regulatory Carrick Therapeutics Receives FDA Fast Track Designations for Two Samuraciclib Combinations for the Treatment of HR+, HER2 Advanced Breast Cancer and Locally Advanced or Metastatic Triple Negative Breast Cancer carricktherapeutics.com ↗ |
| 2021-06-02 | Novartis Pharmaceuticals | Results Novartis Kisqali® reports longest median overall survival in postmenopausal HR+/HER2- metastatic breast cancer patients novartis.com ↗ |
| 2020-12-09 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Updated Results from the Phase II SUMMIT Trial of Neratinib for HER2-Mutant, HR-Positive Metastatic Breast Cancer at SABCS 2020 pumabiotechnology.com ↗
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, presented updated results from the ongoing Phase II SUMMIT trial of neratinib at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place. |
| 2020-09-21 | Novartis Pharmaceuticals | Results Novartis Kisqali® receives the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale novartis.com ↗
A trend toward improved progression free survival (PFS) for Kisqali plus fulvestrant versus palbociclib plus letrozole was also observed. |
| 2020-09-19 | Novartis Pharmaceuticals | Results Novartis Piqray® data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation novartis.com ↗
In SOLAR-1 final analysis, Piqray (alpelisib) plus fulvestrant demonstrated 8 months clinically relevant improvement in overall survival (OS) in HR+/HER2- advanced breast cancer (aBC) patients with a PIK3CA mutation compared to fulvestrant alone |
| 2020-09-17 | Menarini Group | Results Menarini Ricerche Announces Dose Escalation Results Of The Clinical Trial Of Men1611 In Breast Cancer menarini.com ↗
The combination of MEN1611 + trastuzumab +/- fulvestrant has shown an acceptable tolerability profile with no dose-limiting toxicities during the escalation phase, and most treatment emergent adverse events were reversible and manageable with supportive care. |
| 2020-07-29 | Novartis Pharmaceuticals | Regulatory Novartis receives Piqray® approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation novartis.com ↗ |
| 2020-05-29 | Novartis Pharmaceuticals | Regulatory Novartis Piqray® receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation novartis.com ↗ |
| 2020-05-27 | Novartis Pharmaceuticals | Results Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease novartis.com ↗
Results add to body of evidence, reinforce Kisqali consistent overall survival benefit regardless of type of metastases, endocrine partner or menopausal status |
| 2019-12-12 | Novartis Pharmaceuticals | Results Novartis Kisqali® data show superior overall survival compared to fulvestrant and consistent efficacy across advanced breast cancer patient subgroups in MONALEESA-3 novartis.com ↗
The NEJM publication includes new analyses confirming overall survival benefit across all patient sub-groups treated with Kisqali plus fulvestrant. |
| 2019-12-12 | Puma Biotechnology, Inc. | Results plasmaMATCH Trial Shows Neratinib Activity in ERBB2 (HER2) Mutant Metastatic Breast Cancer pumabiotechnology.com ↗ |
| 2019-12-11 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Results from the Phase II SUMMIT Trial of Neratinib for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2019 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
The median duration of response has not been reached and the median progression-free survival was 9.8 months. |
| 2019-09-29 | Novartis Pharmaceuticals | Results Novartis Kisqali® delivers consistently superior overall survival – MONALEESA-3 trial demonstrates more life for postmenopausal HR+/HER2- advanced breast cancer patients novartis.com ↗
In MONALEESA-3, Kisqali plus fulvestrant achieved statistically significant overall survival benefit vs. fulvestrant alone in postmenopausal women (HR=0.724; p=0.00455) |
| 2019-09-29 | Eli Lilly and Company | Results Verzenio® (abemaciclib) Significantly Extends Life by a Median of 9.4 Months for Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2 Study lilly.com ↗
These results were presented today as a late-breaking abstract in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain and simultaneously published in JAMA Oncology. |
| 2019-09-23 | Eli Lilly and Company | Results Lilly Oncology to Present Robust Data across Its Growing Portfolio at ESMO 2019 lilly.com ↗ |
| 2019-08-23 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) |
| 2019-07-31 | Novartis Pharmaceuticals | Results Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials novartis.com ↗
In MONALEESA-3, Kisqali plus fulvestrant achieved statistically significant improvement in overall survival in post-menopausal women in first- and second-line setting |
| 2019-07-30 | Eli Lilly and Company | Results Lilly's Verzenio® (abemaciclib) Significantly Extended Life in Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2 lilly.com ↗
The analysis showed that treatment with Verzenio in combination with fulvestrant met its secondary endpoint of overall survival. |
| 2019-05-24 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis Piqray® - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer novartis.com ↗
Novartis today announced the US Food and Drug Administration (FDA) has approved Piqray ® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen[1]. |
| 2018-12-08 | Novartis Pharmaceuticals | Results Novartis data demonstrates consistent efficacy and tolerability of Kisqali® combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease novartis.com ↗
Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine therapy alone; consistent with the overall study populations |
| 2018-12-06 | Novartis Pharmaceuticals | Results Novartis investigational BYL719 (alpelisib) plus fulvestrant consistently improved PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer in new SOLAR-1 analyses novartis.com ↗
In SOLAR-1, the addition of BYL719 to fulvestrant nearly doubled median progression-free survival (PFS) in patients with PIK3CA mutated HR+/HER2- advanced breast cancer who progressed on or after an aromatase inhibitor (AI) compared to fulvestrant alone. |
| 2018-12-06 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Results from the Phase II SUMMIT Trial of Neratinib for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2018 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
In this cohort, 43 patients (92%) had HER2-non-amplified disease, and patients had received a median of 3 prior lines of therapy in the metastatic setting (range 0-11 prior regimens) before entering the trial. |
| 2018-10-20 | Pfizer | Results Pfizer Presents Overall Survival Data From PALOMA-3 Trial of IBRANCE® (palbociclib) in Patients With HR+, HER2- Metastatic Breast Cancer pfizer.com ↗
The difference in median OS demonstrated in this analysis (6.9 months) is consistent with the improvement previously demonstrated for the primary endpoint of median progression-free survival (mPFS). |
| 2018-10-20 | Novartis Pharmaceuticals | Results Novartis investigational BYL719 (alpelisib) plus fulvestrant nearly doubles median PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer compared to fulvestrant alone novartis.com ↗
Novartis today announced positive results from the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) in combination with fulvestrant. |
| 2018-08-23 | Novartis Pharmaceuticals | Results SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation novartis.com ↗
Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). |
| 2018-06-25 | Pfizer | Results Pfizer Announces Overall Survival Results from Phase 3 PALOMA-3 Trial of IBRANCE® (Palbociclib) in HR+, HER2- Metastatic Breast Cancer pfizer.com ↗
The results demonstrated a positive trend in the hazard ratio favoring the IBRANCE combination, although this trend did not reach statistical significance. |
| 2018-06-03 | Novartis Pharmaceuticals | Results Third Novartis Phase III trial shows Kisqali® combination therapy significantly improves PFS in HR+/HER2- advanced breast cancer novartis.com ↗
MONALEESA-3 showed Kisqali plus fulvestrant significantly prolonged progression-free survival (PFS) compared to fulvestrant alone in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer. |
| 2017-11-15 | AstraZeneca | Regulatory Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib astrazeneca.com ↗ |
| 2017-08-28 | AstraZeneca | Regulatory Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. |
| 2017-07-26 | AstraZeneca | Regulatory Faslodex receives EU approval as first-line therapy for advanced breast cancer astrazeneca.com ↗
AstraZeneca today announced that the European Commission (EC) has approved Faslodex (fulvestrant) for the treatment of oestrogen-receptor positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. |
| 2017-06-23 | AstraZeneca | Regulatory Faslodex (fulvestrant) receives positive CHMP opinion for use in 1st-line hormone receptor-positive advanced breast cancer astrazeneca.com ↗
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Faslodex (fulvestrant) for the treatment of hormone receptor-positive (HR+), locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy. |
| 2017-06-03 | Eli Lilly and Company | Results Lilly Builds Upon Body of Data for Abemaciclib with Phase 3 MONARCH 2 Data Demonstrating Superior Progression-Free Survival in Advanced Breast Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that results from the Phase 3 MONARCH 2 study showed that abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, in combination with fulvestrant, significantly improved progression-free survival (PFS) compared to treatment with fulvestrant alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy (median PFS, 16.4 vs. 9.3 months, respectively, HR: 0.553; 95% CI: 0.449, 0.681, P < .0000001). |
| 2017-03-20 | Eli Lilly and Company | Results Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study of Abemaciclib Met Primary Endpoint of Progression-Free Survival lilly.com ↗
The results demonstrated the addition of abemaciclib to fulvestrant resulted in a statistically significant improvement in PFS, when compared to the control arm of placebo plus fulvestrant. |
| 2016-12-07 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II Trial of PB272 for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2016 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
The presentation at SABCS included an update on both the neratinib monotherapy cohort and the neratinib plus fulvestrant cohort. |
| 2016-09-30 | AstraZeneca | Results AstraZeneca presents new data on Faslodex in breast cancer and provides immuno-oncology update at ESMO 2016 congress astrazeneca.com ↗
Phase III FALCON trial demonstrates superiority of Faslodex over Arimidex in the 1st-line treatment of hormone-receptor positive (HR+) advanced breast cancer |
| 2016-08-10 | Eli Lilly and Company | Results Lilly Provides Update on MONARCH 2 Phase 3 Trial of Abemaciclib lilly.com ↗
INDIANAPOLIS, Aug. 10, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) provided the recommendation to continue the study without modification as the interim efficacy criteria were not met. |
| 2016-05-27 | AstraZeneca | Results AstraZeneca’s Faslodex met primary endpoint in first-line treatment of advanced breast cancer astrazeneca.com ↗
Faslodex 500mg demonstrated superiority compared with Arimidex 1mg in FALCON, and met its primary endpoint of extended progression-free survival. |
| 2015-12-10 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II Trial of PB272 for ERBB2 Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2015 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
For the 3 response-evaluable patients who have been enrolled and received the combination of neratinib plus fulvestrant, 3 (100%) of 3 patients have shown a response, including one patient with a complete response and two patients with partial responses. |
| 2015-05-30 | Pfizer | Results Pfizer Announces Palbociclib More Than Doubled Progression-Free Survival in Phase 3 Trial for Patients With HR+, HER2- Metastatic Breast Cancer Whose Disease Has Progressed Following Endocrine Therapy pfizer.com ↗
The PALOMA-3 results demonstrate that palbociclib in combination with fulvestrant more than doubled the time before disease progression compared to fulvestrant alone |
| 2015-04-15 | Pfizer | Results Pfizer Announces PALOMA-3 Trial For IBRANCE® (Palbociclib) Stopped Early Due To Efficacy Seen In Patients With HR+, HER2- Metastatic Breast Cancer Whose Disease Has Progressed Following Endocrine Therapy pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the Phase 3 PALOMA-3 trial for IBRANCE ® (palbociclib) met its primary endpoint of demonstrating an improvement in progression-free survival (PFS) for the combination of IBRANCE plus fulvestrant compared with fulvestrant plus placebo in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer following disease progression during or after endocrine therapy. |
| 2015-04-13 | AstraZeneca | Results AstraZeneca to showcase strong oncology science at American Association for Cancer Research Annual Meeting 2015 astrazeneca.com ↗
Other key data presented at the meeting come from clinical trials exploring combinations of AZD2014, a novel dual TORC1/2 kinase inhibitor with Faslodex in ER+ breast cancer and with chemotherapy in ovarian and lung cancer and preclinical research on combination regimens. |
All press releases naming this drug 117 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 117 releases opens the full record — a long page | ||
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 521 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fulvestrant | “Patients will be enrolled into the study and assign to receive Palbociclib 125 mg/day orally for 3 weeks followed by 1 week off plus fulvestrant 500 mg intramuscularly on Days...” NCT04318223 ↗512“Options include tamoxifen (20 mg daily), aromatase inhibitors (letrozole 2.5 mg daily, anastrozole 1 mg daily, or exemestane 25 mg daily), or fulvestrant (500 mg...” NCT07708194 ↗ “Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or...” NCT03204734 ↗ “Letrozole:2.5mg,q4w or Anastrozole:1mg,q4w or Exemestane:25mg,q4w or Fulvestrant:Patients will receive intramuscular Fulvestrant on day 1 and day 15 of the first cycle and then...” NCT07810088 ↗ “The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of Fulvestrant for Injectable Suspension vs. the reference drug,...” NCT03324061 ↗ “Endocrine therapy (physician's choice based on prior administered agent including tamoxifen, exemestane, fulvestrant, anastrozole, or letrozole). Endocrine therapy must be...” NCT03184090 ↗ “This single-arm, phase Ib trial evaluated the antitumor activities and safety of afuresertib (apan AKT inhibitor) plus fulvestrant for previously treated HR-positive,...” PMID 41651834 ↗ Feb 2026 “Cohort A is for patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) advanced breast cancer treated with PM in combination with...” NCT06431243 ↗ “Patients with HR-positive, HER2-negative, locally recurrent or metastatic breast cancer were randomized (2:1) to receive culmerciclib plus fulvestrant or matching placebo plus...” PMID 41413016 ↗ Dec 2025 “Futibatinib 20mg once daily on a 28-day cycle and fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on a...” NCT04024436 ↗ “We tested this hypothesis in a phase II neoadjuvant trial of anastrozole and fulvestrant combined with gefitinib in postmenopausal women with newly diagnosed ER-positive breast cancer.” PMID 21792626 ↗ Jul 2011 |
| Known as | Faslodex | “Single-arm study with the primary objective of assessing the efficacy and safety of palbociclib in combination with fulvestrant (Faslodex) in women with HR+, HER2-negative...” NCT04318223 ↗24“The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of Fulvestrant for Injectable Suspension vs. the reference drug,...” NCT03324061 ↗ “A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) Versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell...” NCT00100854 ↗ “Reference Product: Faslodex® (Fulvestrant), 5 mL pre-filled syringe containing 250 mg/5 mL of fulvestrant, administered as two 5 mL injections (total 500 mg) via intramuscular...” NCT06995482 ↗ “The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.” NCT00592007 ↗ “Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose)” NCT03099174 ↗ “Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks Other Names: • Faslodex” NCT06757634 ↗ “A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer” NCT00234403 ↗ “Fulvestrant(which also goes by the tradename, Faslodex) was recently approved by the Food and Drug Administration (FDA) to treat breast cancer.” NCT01186796 ↗ “They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex).” NCT00183963 ↗ “Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment” NCT01602380 ↗ |
| Known as | Fulvestrant (Faslodex) | “Fulvestrant (Faslodex)” NCT02000596 ↗ |
| Known as | Fulvestrant mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1358 ↗ |
| Known as | ICI 182,780 | “Faslodex (Long Acting ICI 182,780)” NCT00635713 ↗ |
| Known as | KSHN001034 | “Open Label Sequential Dosing Single Ascending Dose of Four Cohort and Multiple Dose of One Cohort Pharmacokinetics Tolerability and Safety of Fulvestrant Injection as Test...” NCT06074757 ↗ |
| Known as | NSC #719276 | “Combination Fulvestrant (NSC #719276) Plus ZD1839” NCT00057941 ↗ |
| Known as | NSC-759879 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1358 ↗ |
| Known as | ZD-9238 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1358 ↗ |
| Action | Inhibit | “Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.” NCT00006903 ↗ |
| Modality | Small molecule | “the steroidal anti-oestrogen fulvestrant” PMID 23902874 ↗ Jul 2013 |
| Route | Intramuscular | “Given intramuscularly” NCT00006903 ↗ |
| Target | AR | “fulvestrant downregulates androgen receptor (AR)” NCT00476645 ↗ |