Drugs / Toremifene

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) FARESTON 1997-05-29 fda.gov
Approved EU (EMA) Fareston 1996-02-14 europa.eu

Trials 26 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02271282 Dec 2014 → May 2016 Mayo Clinic Completed No outcome recorded
Phase 29 trials
Phase 2 NCT04383275 Aug 2021 → May 2025 overdue breast cancer Fudan University Recruiting No outcome recorded
Phase 2 NCT02788201 Mar 2017 → Oct 2019 urinary bladder cancer, urothelial carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT03204734 Jan 2016 → Dec 2020 breast cancer Zhejiang Cancer Hospital Unknown No outcome recorded
Phase 2 NCT02353429 Nov 2012 → Jun 2015 desmoid tumor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Unknown No outcome recorded
Phase 2 NCT00437359 May 2007 → May 2017 breast neoplasm Japan Breast Cancer Research Network Terminated No outcome recorded
Phase 2 NCT00020735 Apr 2001 → Jan 2005 prostate cancer Joel Nelson, MD Completed No outcome recorded
Phase 2 NCT00028353 Apr 2001 → Jul 2003 prostate intraepithelial neoplasia GTx Completed No outcome recorded
Phase 2 NCT00003865 Jul 1999 → Feb 2017 ovarian cancer George Washington University Withdrawn No outcome recorded
Phase 2 NCT00002595 Jul 1991 → May 2003 desmoid tumor Advocate Lutheran General Hospital Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02132000 Apr 2014 → May 2020 hormone receptor-positive breast cancer Fengxi Su Unknown No outcome recorded
Phase 312 trials
Phase 3 NCT07153757 Sep 2025 → Sep 2033 expected female breast carcinoma Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT02132390 May 2014 → May 2024 breast cancer, chemotherapy-induced toxicity Peking Union Medical College Hospital Unknown No outcome recorded
Phase 3 NCT02097459 Mar 2014 → Mar 2024 breast cancer Peking Union Medical College Hospital Unknown No outcome recorded
Phase 3 NCT01214291 Mar → Sep 2011 osteoporosis GTx Withdrawn No outcome recorded
Phase 3 NCT01417754 Sep → Nov 2010 Satakunta Central Hospital Completed No outcome recorded
Phase 3 NCT00267553 Nov 2005 → Jun 2006 breast neoplasm Intarcia Therapeutics Terminated No outcome recorded
Phase 3 NCT00106691 Jan 2005 → Feb 2010 prostate intraepithelial neoplasia GTx Completed No outcome recorded
Phase 3 NCT00097344 Dec 2004 → Aug 2006 breast neoplasm Intarcia Therapeutics Terminated No outcome recorded
Phase 3 NCT00129142 Oct 2003 → Nov 2007 osteoporosis, prostate cancer GTx Completed No outcome recorded
Phase 3 NCT00044291 Jun 2002 → Jan 2006 breast neoplasm Intarcia Therapeutics Completed No outcome recorded
Phase 43 trials
Phase 4 NCT03238703 Sep 2018 → Mar 2023 Her2-receptor negative breast cancer, breast carcinoma in situ, female breast carcinoma, invasive breast carcinoma Fred Hutchinson Cancer Center Withdrawn No outcome recorded
Phase 4 NCT02344940 Dec 2014 → Aug 2018 breast cancer Shanghai Jiao Tong University School of Medicine Completed No outcome recorded
Phase 4 NCT02089854 Nov 2014 → Apr 2019 breast cancer Peking Union Medical College Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT05472792 Comparator May 2022 → Apr 2027 expected breast cancer UNC Lineberger Comprehensive Cancer Center Recruiting No outcome recorded
Phase 2 NCT04531748 Comparator Dec 2021 → Sep 2022 COVID-19 Reena Mehra, MD Withdrawn No outcome recorded
Phase 2 NCT02506790 Background Jul 2015 → Aug 2020 breast cancer N.N. Petrov National Medical Research Center of Oncology Unknown No outcome recorded
Phase 33 trials
Phase 3 NCT05891093 Background Jun 2023 → May 2028 expected breast cancer Fudan University Recruiting No outcome recorded
Phase 3 NCT03351062 Comparator Nov 2017 → Dec 2025 female breast carcinoma Chinese Anti-Cancer Association Unknown No outcome recorded
Phase 3 NCT00534846 Comparator Apr 2007 → May 2008 breast disorder Satakunta Central Hospital Completed No outcome recorded

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 34 sources stand behind the page.

FieldValueCited text
Known as toremifene “Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or...” NCT03204734
29

“Premenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 5 years) or Toremifene (60 mg, orally, once daily, for 5 years)” NCT07153757

“premenopausal: tamoxifen or toremifene; postmenopausal: letrozole or anastrozole or exemestane” NCT04383275

“Topotecan, Toremifene, Tretinoin” NCT02788201

NCT00267553

NCT00020735

NCT00097344

NCT02089854

NCT00003865

NCT05472792

NCT02344940

NCT00002529

NCT00002595

NCT00129142

NCT02353429

NCT00010322

NCT03351062

NCT02097459

NCT02132000

NCT00044291

NCT00534846

NCT05891093

NCT02132390

NCT01214291

NCT02506790

NCT04531748

NCT00437359

NCT01417754

NCT02271282

NCT00106691

Known as Acapodene “GTX-006 (Acapodene)” NCT00028353
Known as Chlortamoxifen ChEMBL registry synonym — accepted as the source's own label CHEMBL1655
Known as Fareston “The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene...” NCT00044291
2

“the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer.” NCT00267553

“an FDA-approved drug, toremifene (Fareston®)” NCT00097344

Known as Farestone ChEMBL registry synonym — accepted as the source's own label CHEMBL1655
Known as FC-1157A ChEMBL registry synonym — accepted as the source's own label CHEMBL1655
Known as GTX-006 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00028353
Known as J33.157K ChEMBL registry synonym — accepted as the source's own label CHEMBL1655
Known as NSC-613680 ChEMBL registry synonym — accepted as the source's own label CHEMBL1655
Known as TOR Toremifene (TOR) is a selective oestrogen receptor modulator (SERM) and has comparable efficacy to that of tamoxifen (TAM) in breast cancer patients.” PMID 32677982 Jul 2020
Known as Toremifene citrate Toremifene citrate: 40-mg tablets by mouth once daily.” NCT00437359
1

NCT03238703

Known as Toremifeno ChEMBL registry synonym — accepted as the source's own label CHEMBL1655
Known as Toremiphene ChEMBL registry synonym — accepted as the source's own label CHEMBL1655
Action Inhibit “Hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen.” NCT00003865
Modality Small molecule CHEMBL1655
Route Oral oral toremifene daily for 5 years” NCT00002529