92 completed, 50 recruiting, 42 terminated, 36 active not recruiting. 279 Phase 2, 55 Phase 1, 5 Phase 3.
Follow Fulvestrant: new trials by email Literature Review of Fulvestrant trials Research Report on Fulvestrant
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer Neratinib + endocrine therapy, Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, CDK4/6 + Endocrine therapy - Metastatic Invasive Breast Cancer, Resistant Breast Cancer | Phase 2 | Not yet recruiting | University of California, San Diego | 150 | 2027-07-01 | 2026-07-27 |
| Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety. Alpelisib, Fulvestrant, Trastuzumab - PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation) | Phase 2 | Not yet recruiting | Novartis Pharmaceuticals | 51 | 2026-12-15 | 2026-09-18 |
| A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes Inavolisib, Fulvestrant, Palbociclib - Breast Cancer, Diabetes Type II | Phase 2 | Recruiting | Hoffmann-La Roche | 40 | 2026-10-30 | 2026-10-20 |
| A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations. Zongertinib (BI 1810631), Fulvestrant - Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer | Phase 2 | Not yet recruiting | MedSIR | 25 | 2026-10-04 | 2026-06-01 |
| A Phase 1/2a Study of K-1728 in Advanced Solid Tumors K-1728, Fulvestrant, Palbociclib - Breast Neoplasms, Solid Tumors | Phase 1 / Phase 2 | Not yet recruiting | KymaThera, Inc. | 110 | 2026-10-01 | 2026-10-06 |
| Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer Fulvestaciclib, Trastuzumab, Pertuzumab - Breast Cancer, HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 240 | 2026-10-01 | 2026-07-21 |
| Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs. prifetrastat monotherapy for 15 days then combination with fulvestrant, prifetrastat in combination with fulvestrant - Metastatic (Stage IV) Melanoma | Phase 2 | Not yet recruiting | UNICANCER | 51 | 2026-09-18 | 2026-08-03 |
| Trastuzumab/Pertuzumab With Fulvestrant and Culmerciclib in HR+/HER2+ Early Breast Cancer Trastuzumab (or biosimilar), Pertuzumab, Culmerciclib - Breast Cancer | Phase 2 | Not yet recruiting | Hebei Medical University Fourth Hospital | 31 | 2026-09-01 | 2026-10-19 |
| A Study of AL58805 in Advanced, Metastatic GYN, STS or Breast Cancers AL58805, AL8326, Eribulin - Endometrial Neoplasms, Soft Tissue Sarcoma (STS) | Phase 1 / Phase 2 | Not yet recruiting | Advenchen Pharmaceuticals, LLC. | 138 | 2026-09-01 | 2026-09-10 |
| A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors ATX-898, ATX-898, fulvestrant, ribociclib - Advanced Solid Tumors | Phase 1 / Phase 2 | Recruiting | Antares Therapeutics, Inc | 343 | 2026-08-31 | 2026-10-16 |
| Rash & Diarrhea Prophylaxis With Capivasertib Capivasertib, Loperamide, Fulvestrant - Metastatic HR+/HER2- Breast Cancer | Phase 2 | Recruiting | Maryam Lustberg | 108 | 2026-08-15 | 2026-07-29 |
| Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors ERW316, Fulvestrant, Letrozole - Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors | Phase 1 / Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2026-06-30 | 2026-06-22 | |
| A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy. CDK4/6 inhibitor, Culmerciclib, Fulvestrant - Breast Cancer | Phase 2 | Recruiting | Fudan University | 98 | 2026-06-06 | 2026-06-24 |
| A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer. Inavolisib + Ribociclib + Fulvestrant - Breast Cancer | Phase 2 | Not yet recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 160 | 2026-06-01 | 2026-06-01 |
| Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer Serabelisib, Sapanisertib, Fulvestrant - HR+ HER2- Breast Cancer | Phase 1 / Phase 2 | Recruiting | Faeth Therapeutics | 32 | 2026-04-22 | 2026-07-02 |
| A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer Inavolisib, Ribociclib, Fulvestrant - Breast Cancer | Phase 2 | Recruiting | Hoffmann-La Roche | 80 | 2026-04-07 | 2026-10-06 |
| A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer HRS-6208 Capsule, HRS-6209 Capsule, HRS-8080 Tablet - Advanced Unresectable or Metastatic Breast Cancer of Adults | Phase 1 / Phase 2 | Recruiting | Shandong Suncadia Medicine Co., Ltd. | 180 | 2026-03-27 | 2026-04-03 |
| Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment Tinengotinib at the optimal dose combined with Fulvestrant, Tinengotinib, tinengotinib combined with fulvestrant - Breast Cancer | Phase 2 | Recruiting | TransThera Sciences (Nanjing), Inc. | 94 | 2026-03-17 | 2026-03-27 |
| To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer Inavolisib, Fulvestrant - Breast Cancer | Phase 2 | Recruiting | Hoffmann-La Roche | 80 | 2026-02-18 | 2026-10-06 |
| Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer Ribociclib with fulvestrant, Physician's choice treatments group - Breast Cancer Metastatic | Phase 2 | Not yet recruiting | Yeon Hee Park | 272 | 2026-02-01 | 2025-12-24 |
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Breast Neoplasms (189) · Neoplasm Metastasis (18) · Neoplasms (12) · Ovarian Neoplasms (11) · Endometrial Neoplasms (9) · Carcinoma, Non-Small-Cell Lung (8) · Hereditary Sensory and Autonomic Neuropathies (6) · Prostatic Neoplasms (6) · Squamous Cell Carcinoma of Head and Neck (5) · Uterine Cervical Neoplasms (4) · Colorectal Neoplasms (3) · Head and Neck Neoplasms (3) · Recurrence (3) · Brain Neoplasms (2) · Breast Diseases (2)
Fudan University (14) · AstraZeneca (13) · Novartis Pharmaceuticals (11) · Hoffmann-La Roche (8) · National Cancer Institute (NCI) (7) · Memorial Sloan Kettering Cancer Center (6) · Pfizer (6) · Dana-Farber Cancer Institute (5) · ImmunityBio, Inc. (5) · M.D. Anderson Cancer Center (5) · MedSIR (5) · UNICANCER (5) · Eli Lilly and Company (4) · Sun Yat-sen University (4) · Alliance for Clinical Trials in Oncology (3)
United States (158) · China (50) · United Kingdom (42) · Spain (39) · France (38) · Italy (31) · Germany (28) · Canada (26) · Belgium (25) · South Korea (23) · Australia (18) · Argentina (15) · Brazil (13) · Japan (13) · Taiwan (13)
Anthony D Elias, MD (2) · Donald L. Trump, MD (2) · Min Yan (2) · Mothaffar Rimawi, MD (2) · Sherry Shen, MD (2) · Tufia C. Haddad, M.D. (2)
PMID 32001832, PMID 35181666, PMID 37597578, PMID 16505423, PMID 19153124, PMID 19239974, PMID 20632084, PMID 21792626, PMID 22123186, PMID 22418699, PMID 22444722, PMID 22999294, PMID 23497452, PMID 23798616, PMID 23801303, PMID 24327334, PMID 25892646, PMID 26171933, PMID 27155741, PMID 27315583, PMID 28183331, PMID 28274957, PMID 29326029, PMID 29664714, PMID 29893790, PMID 30223226, PMID 30305115, PMID 31235441, PMID 31314997, PMID 31465093, PMID 31548342, PMID 32035020, PMID 32144133, PMID 32353342, PMID 32385714, PMID 32463152, PMID 32723675, PMID 32919527, PMID 32923853, PMID 33757987, PMID 33761970, PMID 33794206, PMID 33820779, PMID 33893289, PMID 33947745, PMID 34157782, PMID 34217908, PMID 34617955, PMID 34902765, PMID 35013314
2017 (8), 2023 (8), 2014 (5), 2019 (5), 2025 (5), 2015 (4), 2016 (3), 2018 (2), N01CM62204 (2), U10CA180868 (2), UM1CA186704 (2), 2005 (1), N01CM00070 (1), N01CM00099 (1), N01CM62207 (1)