165 completed, 82 recruiting, 72 active not recruiting, 67 terminated. 279 Phase 2, 144 Phase 1, 84 Phase 3, 9 Phase 4, 4 Not applicable.
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 |
| A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer GDC-4198, Fulvestrant, Letrozole - Advanced or Metastatic Breast Cancer | Phase 1 | Not yet recruiting | Genentech, Inc. | 165 | 2026-12-15 | 2026-10-09 |
| 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 |
| Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer Fulvestrant, Pyrotinib, Dalpiciclib - Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer | Phase 3 | Not yet recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 226 | 2026-11-01 | 2026-10-23 |
| Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing NSAI + CDK4/6i, NSAI + CDK4/6i + Capivasertib, Fulvestrant + CDK4/6i + Capivasertib - HR Positive/HER-2 Negative Breast Cancer | Phase 3 | Not yet recruiting | SWOG Cancer Research Network | 1084 | 2026-10-30 | 2026-09-03 |
| 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 |
| Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males Fulvestrant, Anastrozole (ARIMIDEX™) - Inguinal Hernia Unilateral, Inguinal Hernia Bilateral | Phase 1 | Recruiting | Northwestern University | 30 | 2026-10-02 | 2026-10-06 |
| 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 |
| JYP0035 Capsules Plus Fulvestrant in PIK3CA-Mutant HR+/HER2- Advanced Breast Cancer JYP0035 plus Fulvestrant, JYP0035 placebo plus Fulvestrant - Breast Cancer | Phase 3 | Not yet recruiting | Chengdu JOYO pharma Co., Ltd. | 171 | 2026-09-30 | 2026-08-25 |
| 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 |
| 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 |
| 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 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 |
| A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors LAE118, Fulvestrant, Palbociclib - Patients With Advanced Solid Tumors | Phase 1 | Not yet recruiting | Laekna Limited | 150 | 2026-08-01 | 2026-08-26 |
| 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 |
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Breast Neoplasms (340) · Neoplasm Metastasis (41) · Neoplasms (25) · Ovarian Neoplasms (18) · Carcinoma, Non-Small-Cell Lung (14) · Endometrial Neoplasms (12) · Hereditary Sensory and Autonomic Neuropathies (10) · Prostatic Neoplasms (10) · Triple Negative Breast Neoplasms (8) · Colorectal Neoplasms (6) · Breast Diseases (5) · Carcinoma, Ovarian Epithelial (5) · Multiple Endocrine Neoplasia Type 1 (5) · Recurrence (5) · Squamous Cell Carcinoma of Head and Neck (5)
AstraZeneca (36) · Novartis Pharmaceuticals (27) · Fudan University (17) · Eli Lilly and Company (15) · Pfizer (14) · Hoffmann-La Roche (13) · National Cancer Institute (NCI) (10) · Memorial Sloan Kettering Cancer Center (7) · Dana-Farber Cancer Institute (6) · Genentech, Inc. (6) · MedSIR (6) · ImmunityBio, Inc. (5) · M.D. Anderson Cancer Center (5) · Mayo Clinic (5) · Spanish Breast Cancer Research Group (5)
United States (265) · China (109) · Spain (94) · France (85) · United Kingdom (80) · Italy (78) · Germany (66) · Canada (64) · South Korea (60) · Belgium (54) · Australia (53) · Taiwan (39) · Argentina (38) · Japan (38) · Brazil (37)
Cynthia Ma (3) · Sabino De Placido, MD (3) · Anthony D Elias, MD (2) · Antonio Llombart (2) · Claudine Isaacs, MD (2)
PMID 32385714, PMID 38439079, PMID 23902874, PMID 24919854, PMID 27269946, PMID 29522361, PMID 32001832, PMID 33149768, PMID 35181666, PMID 37597578, PMID 38937298, PMID 39177931, PMID 12954578, PMID 16505423, PMID 19153124, PMID 19239974, PMID 20632084, PMID 20938664, PMID 21792626, PMID 22123186, PMID 22418699, PMID 22444722, PMID 22853014, PMID 22999294, PMID 23497452, PMID 23798616, PMID 23801303, PMID 24327334, PMID 25002028, PMID 25348000, PMID 25524798, PMID 25691671, PMID 25892646, PMID 26030518, PMID 26171933, PMID 26371134, PMID 26947331, PMID 27029704, PMID 27155741, PMID 27315583, PMID 27368881, PMID 27908454, PMID 28045625, PMID 28183331, PMID 28274957, PMID 28540640, PMID 28576675, PMID 28580882, PMID 28586789, PMID 28652278
2023 (17), 2017 (11), 2025 (11), 2014 (9), 2015 (8), 2016 (8), 2019 (7), UM1CA186704 (3), 2004 (2), 2018 (2), N01CM00099 (2), N01CM62204 (2), U10CA031946 (2), U10CA180868 (2), 2005 (1)