9 recruiting, 3 active not recruiting, 3 not yet recruiting, 2 completed. 11 Phase 2, 9 Phase 1, 5 Phase 3.
Follow Fulvestrant injection: new trials by email Literature Review of Fulvestrant injection trials Research Report on Fulvestrant injection
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 |
|---|---|---|---|---|---|---|
| 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 |
| A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors IDE574, Fulvestrant injection - ER+, HER 2- Breast Cancer, Non-small Cell Lung Cancer (NSCLC) | Phase 1 | Recruiting | IDEAYA Biosciences | 160 | 2026-03-17 | 2026-06-16 |
| A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations TER-2013, Fulvestrant injection - Breast Cancer, Endometrial Cancer | Phase 1 / Phase 2 | Recruiting | Terremoto Biosciences Inc. | 205 | 2025-09-23 | 2026-09-17 |
| A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer HRS-8080 Tablet, Fulvestrant injection, Exemestane tablets - Locally Advanced Breast Cancer, Metastatic Breast Cancer | Phase 3 | Recruiting | Shandong Suncadia Medicine Co., Ltd. | 240 | 2025-07-23 | 2026-10-02 |
| A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer Sirolimus (albumin - bound), Palbociclib tablet, Fulvestrant injection - Advanced Breast Cancer | Phase 1 | Not yet recruiting | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | 382 | 2025-04-30 | 2025-04-23 |
| Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors Sirolimus for Injection (Albumin-bound), Fulvestrant Injection, Placebo for Sirolimus for Injection (Albumin-bound) - HR+/HER2- Advanced/Metastatic Breast Cancer | Phase 3 | Not yet recruiting | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | 312 | 2025-04-01 | 2025-04-16 |
| Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer Capivasertib, Fulvestrant injection - CCCA Assessed by Ki67 Drop Below <2.7% From Baseline | Phase 2 | Recruiting | GBG Forschungs GmbH | 120 | 2024-12-04 | 2025-04-02 |
| A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE) SIM0270, Everolimus (Afinitor®), Exemestane tablets - Locally Advanced or Metastatic Breast Cancer | Phase 3 | Active not recruiting | Jiangsu Simcere Pharmaceutical Co., Ltd. | 482 | 2024-11-14 | 2026-08-11 |
| A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer Alpelisib Pill, Fulvestrant injection - Endometroid Endometrial Cancer | Phase 2 | Active not recruiting | GOG Foundation | 51 | 2024-09-11 | 2026-07-30 |
| I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers M1774, Fulvestrant injection - Breast Cancer | Phase 1 / Phase 2 | Not yet recruiting | Institut Paoli-Calmettes | 57 | 2024-05-01 | 2024-03-29 |
| A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors JS105, Fulvestrant injection, Dalpiciclib Isetionate Tablets - Advanced Solid Tumors | Phase 1 / Phase 2 | Recruiting | Risen (Suzhou) Pharma Tech Co., Ltd. | 306 | 2024-01-11 | 2025-07-25 |
| A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer TQB2930 for injection, Paclitaxel for injection (albumin-bound), TQB3616 capsule - Metastatic Breast Cancer, Recurrent Breast Cancer | Phase 1 / Phase 2 | Recruiting | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 154 | 2023-04-13 | 2024-03-12 |
| Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study Fulvestrant injection - Metastatic Breast Cancer | Phase 1 | Completed | Kashiv BioSciences, LLC | 48 | 2023-03-01 | 2023-10-10 |
| To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer TQB3616 capsule, Placebo, Fulvestrant injection - HR-positive, HER2-negative Breast Neoplasms | Phase 3 | Active not recruiting | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 432 | 2022-07-01 | 2026-01-07 |
| Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy BEBT-209 capsules, BEBT-209 Placebo capluses, Fulvestrant Injection - HR+/HER2- Locally Advanced, Metastatic Breast Cancer | Phase 3 | Recruiting | BeBetter Med Inc | 330 | 2022-06-09 | 2025-05-31 |
| A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer Palbociclib 125Mg Tab, Fulvestrant injection, Tamoxifen - ER+ Breast Cancer, HER2-negative Breast Cancer | Phase 2 | Recruiting | Royal Marsden NHS Foundation Trust | 1100 | 2022-03-30 | 2024-12-05 |
| Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study) Onapristone, Fulvestrant - ER-positive Breast Cancer, HER2-negative Breast Cancer | Phase 2 | Terminated | University of Wisconsin, Madison | 11 | 2021-10-05 | 2024-05-03 |
| A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer TQB3616 capsules, Fulvestrant injection - HR-positive, HER2-negative Advanced Breast Cancer | Phase 2 | Completed | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 122 | 2021-02-04 | 2026-04-08 |
| A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer TQ-B3525, Fulvestrant injection - HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer | Phase 1 / Phase 2 | Unknown | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 42 | 2020-07-01 | 2020-04-21 |
| Fulvestrant 500mg in Patients With Advanced Breast Cancer Fulvestrant - Metastatic Breast Cancer | Unknown | Fudan University | 500 | 2017-10-11 | 2022-04-20 |
Breast Neoplasms (9) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Endometrial Neoplasms (1) · Esophageal Squamous Cell Carcinoma (1) · Neoplasm Metastasis (1) · Ovarian Neoplasms (1) · Recurrence (1) · Spinocerebellar Degenerations (1) · Squamous Cell Carcinoma of Head and Neck (1) · Uterine Cervical Neoplasms (1)
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (4) · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (2) · Shandong Suncadia Medicine Co., Ltd. (2) · BeBetter Med Inc (1) · Fudan University (1) · GBG Forschungs GmbH (1) · GOG Foundation (1) · IDEAYA Biosciences (1) · Institut Paoli-Calmettes (1) · Jiangsu Simcere Pharmaceutical Co., Ltd. (1) · Kashiv BioSciences, LLC (1) · Risen (Suzhou) Pharma Tech Co., Ltd. (1) · Royal Marsden NHS Foundation Trust (1) · Terremoto Biosciences Inc. (1) · University of Wisconsin, Madison (1)
China (11) · United States (4) · France (2) · Germany (1) · Jordan (1) · Portugal (1) · Puerto Rico (1) · Spain (1) · United Kingdom (1)
Binghe Xu, Ph.D (1) · Dr Uday Harle, Phd medicine (1) · Kari B Wisinski, MD (1) · Nicholas Turner (1) · Sailaja Kamaraju, MD, MS (1) · Sibylle Loibl, Prof. Dr. med. (1) · Stephanie Gaillard, MD (1) · Xichun Hu, MD, PhD (1)
2023 (1)