Drugs / Palbociclib
Palbociclib
also known as
PD-0332991 · IBRANCE · palbociclib (PD0332991) · PAL · Palbociclib isethiolate · palbociclib isethionate · PALBOCICLIBPD-0332991PD0332991IBRANCECS-0019A-1030 · PD 0332991-0054 · +3 more
Small molecule targets CDK4, CDK6, RB1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | IBRANCE | — | 2016-02-19 – 2026-06-24 | fda.gov ↗ |
| Filed | US (FDA) | IBRANCE | HR-positive, HER2-negative advanced or metastatic breast cancer | 2016-12-21 | “the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE ® (palbociclib)” pfizer.com ↗ |
| Approved | EU (EMA) | Ibrance | — | 2016-11-09 | europa.eu ↗ |
| Approved | US (FDA) | IBRANCE | — | 2015-02-03 | fda.gov ↗ |
Trials 295 · started per year
today
US approved 2015
EU approved 2016
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 05 trials | ||||||
| Phase 0 | NCT06959979 | Nov 2024 → Aug 2026 overdue | childhood medulloblastoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
| Phase 0 | NCT04870034 | Jan 2024 → Sep 2025 | colorectal carcinoma, lung adenocarcinoma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT05432518 | Jun 2023 → Jul 2027 expected | adult glioblastoma | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| 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pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |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 0 | NCT04130152 | Nov 2019 → Jan 2022 | breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 179 trials · 1 met primary · 2 missed | ||||||
| Phase 1 | NCT06654297 | Oct 2024 → Jun 2025 overdue | esophageal squamous cell carcinoma | West China Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06113809 | Feb 2024 → Jul 2028 expected | sarcoma | John Rieth | Recruiting | No outcome recorded |
| Phase 1 | NCT05655598 | Sep 2023 → Aug 2024 | endometrial cancer, female breast carcinoma, refractory malignant neoplasm, small cell lung carcinoma +2 | Brown University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05627232 | Aug 2023 → Jan 2028 expected | acute myeloid leukemia | Thomas Jefferson University | 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 | NCT06307249 | Feb 2023 → Dec 2025 overdue | breast cancer, colorectal cancer, lung cancer, ovarian cancer | Lebanese University | Recruiting | No outcome recorded |
| Phase 1 | NCT05238922 | Jul 2022 → Jul 2027 expected | cancer | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05293964 | May 2022 → Dec 2024 overdue | breast cancer | Jiangsu Simcere Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05178888 | Jan 2022 → Jun 2023 | cancer or benign tumor | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05216432 | Dec 2021 → Apr 2027 expected | Her2-receptor negative breast cancer, PIK3CA-related overgrowth spectrum | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT04818632 | Nov 2021 → Sep 2023 | estrogen-receptor positive breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06570031 | Nov 2021 → Apr 2026 | hormone receptor-positive breast cancer | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04996160 | Jul 2021 → Oct 2023 | childhood acute lymphoblastic leukemia | Tanja Andrea Gruber | Completed | No outcome recorded |
| Phase 1 | NCT04498520 | Mar 2021 → Jun 2025 | endometrioid adenocarcinoma, fallopian tube carcinoma, female breast carcinoma, hormone receptor-positive breast cancer +4 | Pamela Munster | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04693468 | Dec 2020 → Dec 2027 expected | high grade malignant neoplasm, metastatic malignant neoplasm | M.D. Anderson Cancer Center | 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 | NCT04360941 | Aug 2020 → Jul 2027 expected | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer, female breast carcinoma, triple-negative breast carcinoma | Royal Marsden NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 1 | NCT04585724 | Jun 2020 → Sep 2021 | female breast carcinoma, metastatic malignant neoplasm in the brain | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04288089 | Apr 2020 → Sep 2022 overdue | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Eisai Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04185883 | Dec 2019 → Dec 2026 expected | cancer | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03900884 | Sep 2019 → Jun 2025 overdue | breast neoplasm | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03959891 | May 2019 → Dec 2022 overdue | breast cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03792256 | Apr 2019 → Jun 2021 | T lymphoblastic leukemia/lymphoma, T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1 | NCT03854903 | Apr 2019 → Nov 2023 | hormone receptor-positive breast cancer | Georgetown University | Completed | No outcome recorded |
| Phase 1 | NCT06065592 | Feb 2019 → Dec 2024 | breast cancer, colorectal cancer, hepatocellular carcinoma, immune system disorder +4 | Lebanese University | Unknown | No outcome recorded |
| Phase 1 | NCT03616587 | Oct 2018 → Sep 2024 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03498378 | Jun 2018 → Feb 2020 overdue | head and neck squamous cell carcinoma | Kathryn Gold | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03455270 | May 2018 → Sep 2022 | breast ductal adenocarcinoma, female breast carcinoma | G1 Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03472573 | May 2018 → Aug 2021 | B-cell acute lymphoblastic leukemia | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT03515200 | Apr 2018 → Jul 2020 | acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT03454035 | Jan 2018 → Jul 2026 overdue | malignant pancreatic neoplasm, melanoma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT03332797 | Nov 2017 → Jul 2027 expected | breast cancer | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03284723 | Nov 2017 → Aug 2021 | breast neoplasm | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT03065387 | Oct 2017 → Oct 2028 expected | metastatic malignant neoplasm, refractory malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03238196 | Aug 2017 → Apr 2021 | breast cancer | Vanderbilt-Ingram Cancer Center | Completed | Met primary |
| Phase 1 | NCT03128619 | Aug 2017 → Mar 2022 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, invasive breast carcinoma, progesterone-receptor positive breast cancer | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03132454 | Jul 2017 → Dec 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03220191 | Jul → Sep 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03170206 | May 2017 → Feb 2023 | lung cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT03065062 | Feb 2017 → Dec 2026 | head and neck cancer, malignant pancreatic neoplasm, squamous cell lung carcinoma | Dana-Farber Cancer Institute | Suspended | No outcome recorded Stop: Business |
| Phase 1 | NCT03006172 | Dec 2016 → Dec 2026 expected | breast cancer | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02897375 | Oct 2016 → Oct 2021 | cancer of unknown primary site, colorectal cancer, female breast carcinoma, head and neck cancer +5 | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT02684032 | Jun 2016 → Jan 2022 | breast cancer | Celcuity Inc | Completed | No outcome recorded |
| Phase 1 | NCT02626507 | Jan 2016 → Feb 2022 | breast cancer | Hoffman Oncology | Unknown | No outcome recorded |
| Phase 1 | NCT02599714 | Dec 2015 → Mar 2018 | breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02501902 | Nov 2015 → Oct 2018 | pancreatic ductal adenocarcinoma | Pfizer | Completed | Missed primary |
| Phase 1 | NCT02499146 | Sep 2015 → Jul 2018 | female breast carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02334800 | Mar 2015 → Oct 2016 | liver disorder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02389842 | Mar 2015 → Oct 2018 | breast cancer | Royal Marsden NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT02311946 | Jan → Apr 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02255461 | Dec 2014 → Feb 2019 | anaplastic astrocytoma, anaplastic oligodendroglioma, childhood brain stem glioma, childhood cerebellar astrocytic neoplasm +11 | Pediatric Brain Tumor Consortium | Terminated | No outcome recorded |
| Phase 1 | NCT02222441 | Oct → Dec 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02159755 | Aug 2014 → Jun 2018 overdue | mantle cell lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02131298 | May → Jun 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02085538 | May 2014 → May 2016 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02065063 | Apr 2014 → Jun 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02097329 | Apr → Jun 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02059330 | Mar → Jun 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02083640 | Mar → May 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02030483 | Feb 2014 → Jul 2016 | plasma cell myeloma | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01976169 | Jan 2014 → May 2021 | breast cancer | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02041273 | Jan → Mar 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02022982 | Jan 2014 → Nov 2017 | lung cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01953731 | Oct 2013 → Jan 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01906125 | Sep 2013 → Jan 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01918176 | Sep → Dec 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01904747 | Jul → Oct 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01802476 | May → Jun 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01756781 | May → Jul 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01821066 | Apr → Aug 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01701375 | Sep 2012 → Apr 2013 | myelodysplastic syndrome | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 1 | NCT01602887 | May → Nov 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01522989 | Dec 2011 → Dec 2020 | high grade malignant neoplasm | Georgetown University | Unknown | No outcome recorded |
| Phase 1 | NCT01320592 | Mar 2011 → May 2019 | breast cancer | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01111188 | Aug 2010 → Feb 2013 | mantle cell lymphoma | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 1 | NCT00420056 | May 2007 → Mar 2010 | mantle cell lymphoma | Pfizer | Completed | Missed primary |
| Phase 1 | NCT00141297 | Sep 2004 → Jul 2008 | non-Hodgkin lymphoma | Pfizer | Completed | No outcome recorded |
| Phase 1/240 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT07861932 | Oct 2026 → Sep 2028 expected | breast neoplasm | KymaThera, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06753747 | Sep 2025 → Sep 2027 expected | esophageal cancer | West China Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06947811 | Jun 2025 → Mar 2027 expected | CDK4 linked melanoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07002177 | Jun 2025 → May 2028 expected | estrogen-receptor positive breast cancer | Forward Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06843967 | Feb 2025 → Aug 2028 expected | dedifferentiated liposarcoma, myxoid liposarcoma, pleomorphic liposarcoma, round cell liposarcoma +1 | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06757335 | Jan 2025 → Jan 2026 overdue | breast cancer | Hinova Pharmaceuticals Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06895733 | Nov 2024 → Dec 2025 overdue | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06364956 | May 2024 → Jun 2026 overdue | urinary bladder cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05665361 | Apr 2024 → Jun 2027 expected | clear cell renal carcinoma, papillary renal cell carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06188520 | Dec 2023 → Aug 2027 expected | estrogen-receptor positive breast cancer, ovarian serous adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05953350 | Nov 2023 → May 2024 overdue | — | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 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 | NCT05563220 | Jan 2023 → Dec 2026 expected | breast cancer | Stemline Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05468697 | Aug 2022 → Jul 2026 overdue | renal cell carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06940349 | Oct 2021 → Jan 2026 overdue | refractory malignant neoplasm | Rabin Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05039177 | Sep 2021 → Aug 2025 | colorectal cancer, pancreatic ductal adenocarcinoma | Erasca, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04669587 | Jul 2021 → Jan 2023 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | EnhancedBio USA Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04802759 | Jun 2021 → May 2029 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04494958 | Nov 2020 → Dec 2023 | triple-negative breast carcinoma | Fundacion Oncosur | Completed | Missed primary |
| Phase 1/2 | NCT04720768 | Jun 2020 → Dec 2024 | melanoma, metastatic neoplasm | Peter MacCallum Cancer Centre, Australia | Unknown | No outcome recorded |
| Phase 1/2 | NCT04072952 | Sep 2019 → Sep 2024 | breast cancer | Arvinas Estrogen Receptor, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03965845 | Jun 2019 → Sep 2021 | non-small cell lung carcinoma | Calithera Biosciences, Inc | Completed | No outcome recorded |
| Phase 1/2 | NCT03844997 | Jun 2019 → Jan 2024 | acute myeloid leukemia | Sudipto Mukherjee, MD, PhD, MPH | Completed | No outcome recorded |
| Phase 1/2 | NCT03560531 | Nov 2018 → Apr 2022 | breast cancer | Zeno Alpha Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03709082 | Oct 2018 → Mar 2020 | HER2 positive breast carcinoma | University of Kansas Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03158389 | May 2018 → Feb 2023 | adult glioblastoma | University Hospital Heidelberg | Completed | Mixed |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03304080 | Dec 2017 → Jul 2026 overdue | breast neoplasm | Icahn School of Medicine at Mount Sinai | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03386929 | Nov 2017 → Dec 2022 | non-small cell lung carcinoma | Worldwide Innovative Network Association | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03054363 | Nov 2017 → Jan 2023 | breast cancer | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1/2 | NCT03284957 | Sep 2017 → Nov 2024 | breast cancer | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03024489 | Jul 2017 → Mar 2024 | head and neck squamous cell carcinoma | Mahidol University | Unknown | No outcome recorded |
| Phase 1/2 | NCT02871791 | Aug 2016 → Dec 2020 | hormone receptor-positive breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02605486 | Nov 2015 → Nov 2026 expected | breast cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02448771 | Jul 2015 → Aug 2019 | invasive breast carcinoma | Dana-Farber Cancer Institute | Completed | Met primary |
| Phase 1/2 | NCT02310243 | Jul 2015 → Jul 2019 | acute lymphoblastic leukemia, acute myeloid leukemia | University of Ulm | Unknown | No outcome recorded |
| Phase 1/2 | NCT02349633 | May 2015 → May 2020 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01823835 | Dec 2014 → Mar 2020 | breast cancer | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT02101034 | Jun 2014 → Jun 2020 | head and neck squamous cell carcinoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT02202200 | May 2014 → Nov 2016 | melanoma | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 2132 trials · 9 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 | NCT07826052 | Sep 2026 → Sep 2031 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07527806 | May 2026 → May 2029 expected | breast cancer | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07191977 | Jan 2026 → Dec 2027 expected | esophageal squamous cell carcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07300215 | Dec 2025 → Nov 2027 expected | breast cancer | The First Affiliated Hospital of Bengbu Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07299890 | Dec 2025 → Nov 2027 expected | breast cancer | Anhui Provincial Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07123090 | Nov 2025 → Oct 2026 expected | clear cell renal carcinoma | Stephanie Berg | 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 |
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07130643 | Dec 2024 → Dec 2026 expected | hormone receptor-positive breast cancer | Xinhong Wu, PhD | Active not recruiting | No outcome recorded |
| Show all 132 trials opens the full record — a long page | ||||||
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02692755 | Sep 2016 → Dec 2019 | hormone receptor-positive breast cancer | Georgetown University | Completed | No outcome recorded |
| Phase 2/3 | NCT02785939 | Sep 2014 → Jun 2017 | non-small cell squamous lung carcinoma | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 326 trials · 7 met primary · 4 missed | ||||||
| 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 | NCT06757634 | Jul 2025 → Mar 2029 expected | breast cancer | Celcuity Inc | Recruiting | No outcome recorded |
| Phase 3 | NCT07005557 | Jun 2025 → May 2030 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06377852 | Oct 2024 → Aug 2028 expected | breast cancer | American Society of Clinical Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT06380751 | Aug 2024 → Dec 2029 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06044623 | Apr 2024 → Oct 2028 expected | breast cancer | Region Örebro County | Recruiting | No outcome recorded |
| Phase 3 | NCT05909397 | Aug 2023 → Dec 2026 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05501886 | Dec 2022 → Jun 2026 overdue | breast cancer | Celcuity Inc | Active not recruiting | Met primary |
| Phase 3 | NCT04966481 | Apr 2022 → Feb 2029 expected | head and neck squamous cell carcinoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 3 | NCT05207709 | Mar 2022 → Mar 2026 | breast cancer | SOLTI Breast Cancer Research Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04862663 | May 2021 → Nov 2027 expected | Her2-receptor negative breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT05429684 | Jan 2021 → Feb 2024 | HER2 positive breast carcinoma | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 3 | NCT04478266 | Oct 2020 → Jun 2022 | breast cancer | Sanofi | Terminated | Missed primary |
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT04047758 | Sep 2019 → Sep 2021 | breast cancer | Shengjing Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03820830 | Aug 2019 → Dec 2026 expected | breast cancer | ETOP IBCSG Partners Foundation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03423199 | Feb 2018 → Sep 2025 | breast cancer | National Cancer Center, Japan | Unknown | Met primary |
| Phase 3 | NCT02947685 | Jun 2017 → Oct 2024 overdue | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer | Alliance Foundation Trials, LLC. | Active not recruiting | Met primary |
| Phase 3 | NCT03079011 | Mar 2017 → Apr 2021 | breast cancer | UNICANCER | Completed | Met primary |
| Phase 3 | NCT02600923 | Apr 2016 → May 2019 | female breast carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02513394 | Aug 2015 → Nov 2020 overdue | breast cancer | Alliance Foundation Trials, LLC. | Active not recruiting | Missed primary |
| Phase 3 | NCT02297438 | Mar 2015 → Aug 2020 | breast neoplasm | Pfizer | Completed | Met primary |
| Phase 3 | NCT02028507 | Mar 2014 → Jan 2019 | breast cancer | Spanish Breast Cancer Research Group | Completed | Missed primary |
| Phase 3 | NCT01864746 | Oct 2013 → Aug 2020 | hormone receptor-positive breast cancer | GBG Forschungs GmbH | Completed | Missed primary |
| Phase 3 | NCT01942135 | Sep 2013 → Dec 2014 | breast cancer | Pfizer | Completed | Met primary |
| Phase 3 | NCT01740427 | Feb 2013 → Feb 2016 | breast cancer | Pfizer | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT05691400 | Mar 2024 → Mar 2027 | leukodystrophy, hypomyelinating, 22 | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04137640 | Jul 2021 → Nov 2025 | breast cancer | Shengjing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03355157 | Mar 2018 → Aug 2024 | breast cancer | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 4 | NCT02679755 | Mar 2016 → Jul 2019 | female breast carcinoma | Pfizer | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT06810492 | Apr → Dec 2025 overdue | female breast carcinoma | Hongmei Zheng, PhD | Not yet recruiting | No outcome recorded |
| — | NCT06856200 | Feb → Oct 2025 overdue | Her2-receptor negative breast cancer, hormone-resistant breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| — | NCT06478927 | Jan 2024 → Jan 2026 overdue | hepatocellular carcinoma | Henan Cancer Hospital | Recruiting | No outcome recorded |
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT03756090 | Dec 2018 → Dec 2019 | breast cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| — | NCT05063058 | Jan 2016 → Nov 2019 | melanoma | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02142868 | — | Her2-receptor negative breast cancer | Pfizer | No longer available | No outcome recorded |
| Comparator or background therapy46 trials | ||||||
| Phase 0 | NCT02913430 Comparator | Apr 2018 → Apr 2022 | breast cancer | Shannon Puhalla | Completed | No outcome recorded |
| Phase 1 | NCT06997029 Background | Aug 2025 → Dec 2028 expected | breast cancer, ovarian cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1 | NCT06941142 Background | Apr 2025 → Oct 2027 expected | breast cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05683418 Background | Feb 2023 → Dec 2027 expected | hormone receptor-positive breast cancer | Totus Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT05384119 Background | Jan 2023 → May 2024 | breast cancer | Tvardi Therapeutics, Incorporated | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05266105 Background | Dec 2021 → Mar 2026 overdue | breast cancer | Olema Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04872608 Background | Sep 2021 → Apr 2023 | breast carcinoma, metastatic neoplasm | Memorial Sloan Kettering Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT04856371 Background | Apr 2021 → Mar 2022 | breast cancer | Haihe Biopharma Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04060862 Background | Nov 2019 → Aug 2023 | breast cancer | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03471663 Background | Mar 2018 → Oct 2023 | breast cancer | InventisBio Co., Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT07173556 Background | Sep 2025 → Feb 2027 expected | breast cancer | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06736704 Background | Feb 2025 → Apr 2027 expected | cancer | Pikavation Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05768139 Background | Apr 2023 → Jul 2030 expected | breast cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04946864 Background | Aug 2021 → Aug 2024 | breast cancer | Ascentage Pharma Group Inc. | Suspended | No outcome recorded |
| Phase 1/2 | NCT03774472 Background | Aug 2018 → Apr 2024 | female breast carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT07180160 Background | Sep 2025 → Sep 2027 expected | female breast carcinoma | Wenjin Yin | Recruiting | No outcome recorded |
| Phase 2 | NCT06486883 Comparator | Jun 2025 → Jan 2027 expected | hormone receptor-positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT06207734 Comparator | Jan 2024 → Jan 2027 expected | breast cancer | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT06176534 Comparator | Jan 2024 → Dec 2025 overdue | Her2-receptor negative breast cancer, female breast carcinoma | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04920708 Background | Dec 2022 → Jun 2027 expected | estrogen-receptor positive breast cancer | Royal Marsden NHS Foundation Trust | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04819243 Background | Aug 2021 → Dec 2025 overdue | hormone receptor-positive breast cancer | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04563507 Comparator | Nov 2020 → Oct 2027 expected | breast cancer | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 2 | NCT04220476 Comparator | Mar 2020 → Dec 2025 | breast cancer | Weill Medical College of Cornell University | Withdrawn | No outcome recorded |
| Phase 2 | NCT03819010 Comparator | May → Jul 2019 | breast cancer | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT03573648 Comparator | Nov 2018 → Dec 2026 expected | breast cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03377101 Background | Aug 2018 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT03227328 Comparator | Aug 2017 → Feb 2022 | hormone receptor-positive breast cancer | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Completed | No outcome recorded |
| Phase 2 | NCT02630693 Comparator | Apr 2016 → Aug 2018 | breast cancer | Canadian Cancer Trials Group | Completed | No outcome recorded |
| Phase 2/3 | NCT04191499 Background | Jan 2020 → Sep 2023 overdue | breast cancer | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT07802626 Comparator | Oct 2026 → Oct 2034 expected | hormone receptor-positive breast cancer | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07492641 Comparator | May 2026 → Apr 2029 expected | hormone receptor-positive breast cancer | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT07174336 Background | Dec 2025 → May 2029 expected | breast neoplasm, metastatic neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07061717 Comparator | Jul 2025 → Jul 2029 expected | hormone receptor-positive breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06760637 Comparator | Jan 2025 → Jan 2029 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06065748 Background | Dec 2023 → Apr 2028 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05670054 Comparator | Mar 2022 → Oct 2023 | female breast carcinoma | Mansoura University | Unknown | No outcome recorded |
| Phase 3 | NCT04964934 Background | Jun 2021 → Jun 2025 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT04711252 Background | Jan 2021 → Jun 2026 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | Missed primary |
| Phase 3 | NCT04546009 Background | Oct 2020 → Jan 2026 overdue | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Active not recruiting | Missed primary |
| Phase 3 | NCT03969121 Comparator | Jul 2019 → Dec 2021 | female breast carcinoma, hormone receptor-positive breast cancer | Kyoto Breast Cancer Research Network | Completed | No outcome recorded |
| Phase 3 | NCT03447132 Comparator | Dec 2017 → Apr 2021 | breast cancer | International Cancer Research Group, United Arab Emirates | Completed | No outcome recorded |
| Phase 3 | NCT03425838 Comparator | Nov 2017 → Mar 2023 overdue | breast cancer | Dutch Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07487129 Comparator | Aug 2024 → Oct 2025 | breast cancer | Beni-Suef University | Completed | No outcome recorded |
| Phase 4 | NCT05949424 Comparator | May 2024 → Mar 2025 | breast carcinoma, endometrial carcinoma, ovarian carcinoma, renal cell carcinoma +1 | University Medical Center Groningen | Unknown | No outcome recorded |
| Phase 4 | NCT03220178 Background | Jul 2017 → Dec 2021 | breast cancer | Palleos Healthcare GmbH | Terminated | No outcome recorded |
| — | NCT03870919 Background | Oct 2019 → Aug 2024 overdue | female breast carcinoma | UNICANCER | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 70
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | Alexion Pharmaceuticals, Inc. | Results Update on SERENA-4 Phase III trial of Etcamah in combination with palbociclib in upfront 1st-line advanced ER-positive breast cancer astrazeneca.com ↗
The SERENA-4 Phase III trial of AstraZeneca’s Etcamah (camizestrant) in combination with palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, did not meet the primary endpoint of progression-free survival (PFS), however a numerical improvement was observed in the upfront 1st-line treatment of patients with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer who have not received any systemic treatment for advanced disease. |
| 2026-09-04 | Alexion Pharmaceuticals, Inc. | Regulatory Etcamah in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer astrazeneca.com ↗ |
| 2026-07-23 | AstraZeneca | Regulatory Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1st-line advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2026-06-24 | Pfizer | Regulatory FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance pfizer.com ↗
With today’s FDA approval, IBRANCE becomes the first and only CDK4/6 inhibitor indicated for patients with HR+ metastatic breast cancer regardless of HER2 status, extending its impact to patients who continue to face challenges with treatment resistance. |
| 2026-06-02 | AstraZeneca | Results Camizestrant combination delayed time to first progression by 55% and to second progression by 37% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 trial astrazeneca.com ↗
Median PFS2 was 25.7 months for the camizestrant combination compared with 19.1 months for the AI combination. |
| 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). |
| 2026-05-22 | AstraZeneca | Regulatory Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2026-05-19 | Hoffmann-La Roche | Results Roche to present new data at ASCO 2026, reinforcing giredestrant's potential to transform the treatment paradigm in early breast cancer roche.com ↗
Primary results from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease |
| 2026-05-18 | Genentech, Inc. | Results Genentech to Present New Data at ASCO 2026, Reinforcing Giredestrant's Potential to Transform the Treatment Paradigm in Early Breast Cancer gene.com ↗
Primary results from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease |
| 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. |
| 2026-03-09 | Hoffmann-La Roche | Results [Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase III persevERA study in ER-positive advanced breast cancer roche.com ↗
The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. |
| 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.” |
| 2026-03-08 | Genentech, Inc. | Results Genentech Provides Update on Phase III persevERA Study in ER-Positive Advanced Breast Cancer gene.com ↗
The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. |
| 2025-06-01 | AstraZeneca | Results Camizestrant reduced the risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial astrazeneca.com ↗
Results showed the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.31–0.60; p<0.00001) as assessed by investigator. |
| 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 |
| 2025-02-26 | AstraZeneca | Results Camizestrant demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival in 1st-line advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial astrazeneca.com ↗ |
| 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. |
| 2024-12-12 | Pfizer | Results Pfizer’s IBRANCE® in Combination with Standard-of-Care Therapies Extends Median Progression-Free Survival by Over 15 Months in Phase 3 PATINA Study in Patients with HR+, HER2+ Metastatic Breast Cancer pfizer.com ↗
This represents an extension in median PFS of over 15 months. |
| 2024-12-05 | Pfizer | Results Pfizer Showcases Scientific Leadership in Breast Cancer and Blood Disorders Across More than 100 Presentations at ASH and SABCS pfizer.com ↗
In P-VERIFY, the largest-ever real-world comparative overall survival analysis of first-line CDK4/6 inhibitors plus aromatase inhibitor (AI) therapy in HR+/HER2- MBC, numerically similar overall survival rates were observed across CDK4/6 inhibitor groups at 12, 24, and 30 months. |
| 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 ↗ |
| 2024-06-28 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - PALBOCICLIB TABLETS OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗
The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Palbociclib Tablets (125mg) (the “Product”), developed by the Group, has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China, and is deemed to have passed the consistency evaluation of quality and efficacy of generic drugs. |
| 2024-05-24 | Menarini Group | Results Menarini Group Presents Updated Data from ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2024 Annual Meeting menarini.com ↗
Updated analysis from the ELEVATE study demonstrates that all evaluable elacestrant plus targeted therapy combination arms are consistent with the known safety profiles of everolimus, alpelisib, ribociclib and palbociclib plus standard of care endocrine therapy. |
| 2024-05-16 | Arvinas Inc. | Results Arvinas and Pfizer Announce Updated Clinical Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) arvinas.com ↗
After six months of additional follow-up, clinical benefit rate (63%), overall response rate (41.9%), median progression-free survival (11.2 months), and safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023 |
| 2023-12-11 | Menarini Group | Results Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium menarini.com ↗
A preliminary analysis of data in the phase 1b part of the ELEVATE trial demonstrates antitumor activity of the combination evaluating ORSERDU with inhibitors of the PI3K/AKT/mTOR pathway and CDK 4/6 inhibitors. |
| 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. |
| 2023-12-05 | Arvinas Inc. | Results Arvinas and Pfizer Announce Interim Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) and Plans to Expand Vepdegestrant Development Program arvinas.com ↗
Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced clinical data for vepdegestrant (ARV-471), a novel oral PROteolysis TArgeting Chimera (PROTAC ® ) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE ® ). |
| 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 |
| 2023-06-28 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Palbociclib Tablets, 75 mg, 100 mg, and 125 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Palbociclib Tablets, 75 mg, 100 mg, and 125 mg (USRLD: Ibrance Tablets, 75 mg, 100 mg, and 125 mg). |
| 2023-06-05 | Erasca, Inc. | Results Erasca Provides Update on Clinical Program for ERK Inhibitor ERAS-007 and Refines Pipeline erasca.com ↗
Due to a lack of clinical activity, we will not continue exploring ERAS-007 combined with palbociclib in patients with RAS-mutated gastrointestinal malignancies |
| 2023-05-25 | Erasca, Inc. | Results Erasca to Present Promising Preliminary HERKULES-3 Phase 1b Data at the 2023 ASCO Annual Meeting erasca.com ↗
ERAS-007 in combination with cell cycle inhibitor palbociclib will not be pursued further in patients with RAS-mutated gastrointestinal (GI) malignancies |
| 2023-05-05 | Arvinas Inc. | Results Arvinas Reports First Quarter 2023 Financial Results and Provides Corporate Update arvinas.com ↗
Preliminary data from the Phase 1b combination trial of vepdegestrant + palbociclib suggests potential clinical benefit in a heavily pretreated patient population |
| 2022-06-04 | Pfizer | Results Pfizer Announces Overall Survival Results from Phase 3 PALOMA-2 Trial of IBRANCE® (palbociclib) for the First-Line Treatment of ER+, HER2- Metastatic Breast Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced overall survival (OS) results from the Phase 3 PALOMA-2 trial, which evaluated IBRANCE® (palbociclib) in combination with letrozole compared to placebo plus letrozole for the first-line treatment of postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). |
| 2022-05-27 | Ascentage Pharma Group Inc. | Results ASCO 2022 | Ascentage Pharma Presents Updated Results from Multiple Clinical Studies Demonstrating Rapid Progress in Global Clinical Development ascentage.com ↗ |
| 2022-04-14 | Ascentage Pharma Group Inc. | Results AACR 2022 | Ascentage Presents Six Preclinical Studies ascentage.com ↗
FAK inhibitor APG-2449 and CDK4/6 inhibitor palbociclib synergistically suppress mesothelioma tumor growth via autophagy induction |
| 2022-03-09 | Ascentage Pharma Group Inc. | Results Ascentage to Present Six Preclinical Studies at AACR 2022 ascentage.com ↗
APG-2449 FAK inhibitor APG-2449 and CDK4/6 inhibitor palbociclib synergistically suppress mesothelioma tumor growth via autophagy induction |
| 2021-05-19 | Sanofi | Results Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breast cancer sanofi.com ↗
Amcenestrant, an investigational oral selective estrogen receptor degrader (SERD), achieved an objective response rate of 34% and a clinical benefit rate of 74% in Phase 1 study (AMEERA-1) in combination with palbociclib |
| 2021-04-12 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Releases Preclinical Data of Its Core Drug Candidates at AACR Annual Meeting 2021, with Results Signifying the Potential of Multiple Combination Therapies in Cancer ascentage.com ↗
We have shown that clinical-stage BCL-2 selective inhibitor APG-2575 enhances antitumor activity when combined with palbociclib in ER⁺ breast cancer xenograft models, including malignancies that are resistant to tamoxifen or progress after CDK4/6i treatment. |
| 2021-03-25 | Pfizer | Results Real-World Evidence Supports Effectiveness of First-line IBRANCE® (palbociclib) Combination Therapy in HR+, HER2- Metastatic Breast Cancer pfizer.com ↗
Median OS was not reached among patients in the IBRANCE group and was 43.1 months among patients in the letrozole group (HR 0.66: 95% CI, 0.53 to 0.82; P=0.0002). |
| 2020-12-03 | AstraZeneca | Results AstraZeneca demonstrates growing leadership in breast cancer at SABCS with data from its innovative medicines and robust pipeline astrazeneca.com ↗ |
| 2020-10-09 | Pfizer | Results PENELOPE-B Trial of IBRANCE® (palbociclib) in Early Breast Cancer Did Not Meet Primary Endpoint pfizer.com ↗ |
| 2020-09-24 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from USFDA for Palbociclib Capsules zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Palbociclib Capsules, (US RLD: Ibrance Capsules) in the strengths of 75 mg, 100 mg, and 125 mg. |
| 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. |
| 2020-05-29 | Pfizer | Results Pfizer Provides Update on Phase 3 PALLAS Trial of IBRANCE® (palbociclib) Plus Endocrine Therapy in HR+, HER2- Early Breast Cancer pfizer.com ↗
No unexpected new safety signals were observed in patients receiving palbociclib. |
| 2020-05-15 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present Six Abstracts at 2020 AACR Annual Meeting ascentage.com ↗
We demonstrated that Combining APG-2575 with tamoxifen or palbociclib therapies substantially enhanced antitumor activity and overcomes tamoxifen resistance in the preclinical models of ER+ breast cancer, suggesting a novel strategy for the clinical development of BCL-2 inhibitors in ER+ breast cancers. |
| 2019-09-24 | Pfizer | Results Pfizer Presents New Evidence of IBRANCE® (palbociclib) Effectiveness in HR+, HER2- Metastatic Breast Cancer Patients in Four Real-World Studies at ESMO Congress 2019 pfizer.com ↗
In this retrospective analysis ( Abstract #329P: Comparative effectiveness of palbociclib plus letrozole vs. letrozole for metastatic breast cancer in U.S. real-world clinical practices) , treatment with IBRANCE plus letrozole demonstrated a statistically significant improvement in real-world progression-free survival (rwPFS) compared to letrozole alone: 24.5 months (95% CI = 20.7 – 32.7) versus 17.1 months (95% CI = 13.7 – 19.8) (HR = 0.68, 95% CI = 0.56 – 0.84, p = 0.0003). |
| 2019-04-04 | Pfizer | Regulatory U.S. FDA Approves IBRANCE® (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer pfizer.com ↗
With today’s approval, IBRANCE is the first and only CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of men with HR+, HER2- metastatic breast cancer in the U.S. |
| 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). |
| 2018-06-25 | 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. |
| 2017-12-06 | Pfizer | Results Updated Data from Phase 3 Trial of IBRANCE® (palbociclib) Plus Letrozole in ER+, HER2- Metastatic Breast Cancer Confirm Improvement in Progression-Free Survival pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced updated progression-free survival (PFS) results from the Phase 3 PALOMA-2 trial reinforcing the clinical benefit of IBRANCE® (palbociclib) combined with letrozole. |
| 2017-03-31 | Pfizer | Regulatory IBRANCE® (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer pfizer.com ↗
The FDA action converts the accelerated approval of IBRANCE to regular approval and broadens the range of anti-hormonal therapy that may be administered with IBRANCE. |
| 2016-12-21 | Pfizer | Regulatory FDA Accepts Supplemental New Drug Application for Pfizer’s IBRANCE® (palbociclib) in HR+, HER2- Metastatic Breast Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE ® (palbociclib). |
| 2016-12-19 | Pfizer | Results Pfizer Presents Data from PALOMA-2 Phase 3 Study Demonstrating Clinical Benefit of IBRANCE® (palbociclib) in Asian Women with ER+, HER2- Metastatic Breast Cancer at ESMO Asia Congress pfizer.com ↗
Results showed the combination of IBRANCE and letrozole significantly extended progression-free survival (PFS) by more than 11 months compared with letrozole plus placebo, and demonstrated that the median PFS exceeded two years in these patients. |
| 2016-11-16 | Pfizer | Results PALOMA-2 Phase 3 Study Published In The New England Journal Of Medicine Demonstrates Clinical Benefit Of Pfizer’s IBRANCE® (palbociclib) In First-Line ER+, HER2- Metastatic Breast Cancer pfizer.com ↗
The PALOMA-2 study showed the combination of IBRANCE and letrozole extended progression-free survival (PFS), or the amount of time before tumor growth, by more than 10 months compared with letrozole plus placebo. |
| 2016-11-09 | Pfizer | Regulatory IBRANCE® (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the European Commission (EC) has approved IBRANCE ® (palbociclib) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. |
| 2016-09-16 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion For IBRANCE® (palbociclib) In Combination With Endocrine Therapy For The Treatment Of HR+/HER2- Metastatic Breast Cancer In Europe pfizer.com ↗
The CHMP’s positive opinion is for IBRANCE to be used in combination with an aromatase inhibitor, as well as in combination with fulvestrant in women who have received prior endocrine therapy. |
| 2016-04-19 | Pfizer | Results Pfizer Announces Positive Top-Line Results for Phase 3 PALOMA-2 Clinical Trial of IBRANCE® (palbociclib) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced positive top-line results from the Phase 3 PALOMA-2 trial for IBRANCE ® (palbociclib), an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. |
| 2016-02-19 | Pfizer | Regulatory Pfizer Receives Expanded FDA Approval For IBRANCE (palbociclib) In HR+, HER2- Metastatic Breast Cancer pfizer.com ↗
Now IBRANCE also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. |
| 2015-12-10 | Pfizer | Regulatory Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE® (palbociclib). |
| 2015-08-20 | Pfizer | Regulatory Pfizer Announces European Medicines Agency Validates Marketing Authorization Application for IBRANCE® (palbociclib) in Combination with Endocrine Therapy for the Treatment of HR+/HER2- Metastatic Breast Cancer pfizer.com ↗
Pfizer Inc. today announced that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for IBRANCE ® (palbociclib) in combination with endocrine therapy for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. |
| 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 ↗ |
| 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. |
| 2015-02-03 | Pfizer | Regulatory Pfizer Receives U.S. FDA Accelerated Approval of IBRANCE® (palbociclib) pfizer.com ↗
Pfizer Inc. today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of IBRANCE ® (palbociclib), in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease. |
All press releases naming this drug 80 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 345 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Palbociclib | “Palbociclib (PD-0332991) is an oral, small-molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6 with preclinical evidence of growth-inhibitory activity in oestrogen...” PMID 25524798 ↗ Dec 2014322“Full initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or...” NCT06044623 ↗ “Palbociclib is a highly selective, reversible, oral inhibitor of cyclin-dependent kinases 4 and 6 that is approved to treat hormone receptor-positive/human epidermal growth...” PMID 32420697 ↗ May 2020 “Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive,...” NCT05670054 ↗ “A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women...” NCT01756781 ↗ “Patient receive standard endocrine therapy (ETH) in combination with Palbociclib. palbociclib administered according to standard dosing regimen (125mg /day ) for 3 consecutive...” NCT07487129 ↗ “Palbociclib is an investigational (experimental) drug that works to induce early G1 arrest by inhibiting CDK4/6, which are two types of CDKs that are overexpressed in AML cell...” NCT03844997 ↗ “An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.” NCT00420056 ↗ “Phase I-II Open-Label Multicenter Study of Palbociclib + Vemurafenib in BRAF (V600MUT) Metastatic Melanoma Patients: Uncovering CHEK2 as a Major Response Mechanism.” PMID 33947696 ↗ May 2021 “Phase 1/2 study of cyclin-dependent kinase (CDK)4/6 inhibitor palbociclib (PD-0332991) with bortezomib and dexamethasone in relapsed/refractory multiple myeloma.” PMID 25813205 ↗ May 2015 “Palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, blocks proliferation in a RB and cyclin D-dependent manner in preclinical prostate cancer models.” PMID 33727260 ↗ Mar 2021 |
| Known as | IBRANCE | “This phase I study estimated the effect of food on bioavailability of palbociclib (IBRANCE®), and a selective inhibitor of cyclin-dependent kinase 4/6 approved for oncology...” PMID 28204912 ↗ Feb 20177“(1) Palbociclib (trade name: Ibrance®; Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; imported drug license No. H20180040): 125 mg/capsule, 1 capsule by mouth once a day” NCT04047758 ↗ “The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma.” NCT01209598 ↗ “Palbociclib (Ibrance) is an oral capsule or tablet administered once daily with food on Days 1-21 of every 28-day cycle in combination with telaglenestat.” NCT03965845 ↗ “Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCE” NCT06757634 ↗ “Palbociclib (IBRANCE®) is a kinase inhibitor FDA approved for the following indications:” NCT06843967 ↗ “Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days” NCT03194373 ↗ “palbociclib (Ibrance®️, Pfizer Inc.)” NCT05266105 ↗ |
| Known as | PAL | “Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive,...” NCT05670054 ↗ |
| Known as | palbociclib (PD0332991) | “palbociclib (PD0332991)” NCT02806648 ↗4“palbociclib, PD-0332991” NCT01953731 ↗ “Palbociclib, PD-0332991” NCT02334800 ↗ “Palbociclib, PD-0332991” NCT02222441 ↗ “Palbociclib=PD-0332991” NCT01976169 ↗ |
| Known as | Palbociclib isethiolate | ChEMBL registry synonym — accepted as the source's own label CHEMBL189963 ↗ |
| Known as | palbociclib isethionate | “This phase I trial studies the side effects and best dose of palbociclib isethionate in treating younger patients with central nervous system tumors that have grown, come back,...” NCT02255461 ↗ |
| Known as | PALBOCICLIBPD-0332991PD0332991IBRANCECS-0019A-1030 | ChEMBL registry synonym — accepted as the source's own label CHEMBL189963 ↗ |
| Known as | PD 0332991-0054 | ChEMBL registry synonym — accepted as the source's own label CHEMBL189963 ↗ |
| Known as | PD-0332991 | “A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The...” NCT01684215 ↗40“Phase I Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell...” NCT03065062 ↗ “An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.” NCT00420056 ↗ “A Phase 1, Open-Label, 6 Sequence, 3 Period, Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Estimate The Relative Bioavailability Of 3 Palbociclib Formulations” NCT02083640 ↗ “A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]” NCT02297438 ↗ “The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma.” NCT01209598 ↗ “A Phase 1, Open-label, Single Dose, Parallel-group Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Renal Function” NCT02085538 ↗ “A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)” NCT01740427 ↗ “Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)” NCT01942135 ↗ “A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)” NCT01802476 ↗ “Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)” NCT01918176 ↗ |
| Known as | PD-0332991, palbociclib | “PD-0332991, palbociclib” NCT01821066 ↗ |
| Known as | PF-00080665-73 | ChEMBL registry synonym — accepted as the source's own label CHEMBL189963 ↗ |
| Known as | PFE-PKIS 32 | ChEMBL registry synonym — accepted as the source's own label CHEMBL189963 ↗ |
| Action | Inhibit | “PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors).” NCT00141297 ↗ |
| Modality | Small molecule | “Palbociclib (PD-0332991) is an oral, small-molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6 with preclinical evidence of growth-inhibitory activity in oestrogen...” PMID 25524798 ↗ Dec 2014 |
| Route | Oral | “Dose ranging study - evaluating two oral schedule: (1) 3/1 Schedule - PD-0332991 administered days 1-21 of a 28-day schedule, doses ranging from 25 to 150 mg once daily; (2)...” NCT00141297 ↗ |
| Target | CDK4 | “selective CDK4/6 inhibitor PD0332991” PMID 22383795 ↗ Mar 2012 |