26 active not recruiting, 23 completed, 12 recruiting, 9 terminated. 84 Phase 3, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 84 | Active not recruiting 26, Completed 23, Recruiting 12, Terminated 9, Unknown 9, Not yet recruiting 5 |
| Phase 2 | 5 | Active not recruiting 2, Completed 2, Unknown 1 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer Placebo + fulvestrant, NTQ1062+Fulvestrant - HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer | Phase 3 | Not yet recruiting | Nanjing Chia-tai Tianqing Pharmaceutical | 210 | 2026-02-10 | 2026-02-06 |
| A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) LY4064809, Placebo, Ribociclib - Breast Neoplasms, Neoplasm Metastasis | Phase 3 | Recruiting | Eli Lilly and Company | 800 | 2025-12-22 | 2026-10-08 |
| A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution - Breast Cancer | Phase 3 | Recruiting | Risen (Suzhou) Pharma Tech Co., Ltd. | 312 | 2025-11-12 | 2025-12-30 |
| Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer Zovegalisib, Capivasertib, Fulvestrant - PIK3CA Mutation, HER2- Negative Breast Cancer | Phase 3 | Recruiting | Relay Therapeutics, Inc. | 540 | 2025-08-26 | 2026-10-05 |
| A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. PF-07248144, Fulvestrant, Everolimus - Breast Cancer | Phase 3 | Recruiting | Pfizer | 400 | 2025-08-05 | 2026-10-19 |
| Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole - Breast Cancer | Phase 3 | Recruiting | Celcuity Inc | 1180 | 2025-07-24 | 2026-10-09 |
| 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 |
| 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 |
| A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain Fulvestrant, Capivasertib - Locally Advanced or Metastatic Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 101 | 2025-01-07 | 2026-10-15 |
| 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 |
| Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. futibatinib, futibatinib, fulvestrant - Advanced/Metastatic Cancer | Phase 2 / Phase 3 | Active not recruiting | Taiho Oncology, Inc. | 15 | 2024-10-01 | 2026-07-28 |
| Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients Capivasertib, Fulvestrant - Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 293 | 2024-09-26 | 2026-08-17 |
| Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer Saruparib (AZD5305), Camizestrant, Abemaciclib - Advanced Breast Cancer | Phase 3 | Recruiting | AstraZeneca | 788 | 2024-08-01 | 2026-09-02 |
| Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer Apatinib, CDK4/6 Inhibitor, Aromatase inhibitor and Fulvestrant - Advanced Breast Cancer, HR+/HER2- Breast Cancer | Phase 3 | Active not recruiting | Fudan University | 184 | 2024-06-11 | 2026-09-25 |
| A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) Giredestrant, Fulvestrant, Abemaciclib - Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer | Phase 3 | Active not recruiting | Hoffmann-La Roche | 1050 | 2023-12-11 | 2026-09-14 |
| OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer Palazestrant, Fulvestrant, Anastrozole - Breast Cancer, Advanced Breast Cancer | Phase 3 | Active not recruiting | Olema Pharmaceuticals, Inc. | 510 | 2023-11-16 | 2026-08-13 |
| Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib - Metastatic Breast Cancer | Phase 3 | Recruiting | LeonaBio | 600 | 2023-10-31 | 2026-06-22 |
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Breast Neoplasms (69) · Neoplasm Metastasis (13) · Neoplasms (5) · Hereditary Sensory and Autonomic Neuropathies (2) · Multiple Endocrine Neoplasia Type 1 (2) · Recurrence (2) · Breast Diseases (1) · Carcinoma, Ductal, Breast (1) · Carcinoma, Lobular (1) · Cholangiocarcinoma (1) · Disease Progression (1) · Neoplasms by Site (1) · Unilateral Breast Neoplasms (1)
AstraZeneca (14) · Novartis Pharmaceuticals (7) · Eli Lilly and Company (5) · Hoffmann-La Roche (4) · Spanish Breast Cancer Research Group (4) · Consorzio Oncotech (3) · Pfizer (3) · SWOG Cancer Research Network (3) · Celcuity Inc (2) · Alliance Foundation Trials, LLC. (1) · Alliance for Clinical Trials in Oncology (1) · BeBetter Med Inc (1) · Betta Pharmaceuticals Co., Ltd. (1) · Borstkanker Onderzoek Groep (1) · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (1)
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Sabino De Placido, MD (3) · A E van Leeuwen-Stok, PhD (1) · A. Jager, MD, PhD (1) · Aleix Prat, MD (1) · Anthony Howell, MD (1) · Binghe Xu (1) · Binghe Xu, MD (1)
PMID 23902874, PMID 27269946, PMID 29522361, PMID 12954578, PMID 20938664, PMID 22853014, PMID 25348000, PMID 25524798, PMID 25691671, PMID 26030518, PMID 26371134, PMID 26947331, PMID 27029704, PMID 27368881, PMID 27908454, PMID 28045625, PMID 28576675, PMID 28580882, PMID 28586789, PMID 28652278, PMID 29223745, PMID 29342248, PMID 29574365, PMID 29860922, PMID 30032196, PMID 30053671, PMID 30241001, PMID 30308388, PMID 30345905, PMID 30392115, PMID 30458732, PMID 30807234, PMID 30917258, PMID 31091374, PMID 31127500, PMID 31152327, PMID 31276981, PMID 31305131, PMID 31426673, PMID 31563959, PMID 31826360, PMID 32164785, PMID 32416251, PMID 32783178, PMID 33149768, PMID 33186740, PMID 33246021, PMID 33369581, PMID 33385521, PMID 33392835
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