8 unknown, 6 recruiting, 5 active not recruiting, 5 completed. 28 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 28 | Unknown 8, Recruiting 6, Active not recruiting 5, Completed 5, Terminated 2, Not yet recruiting 1, Withdrawn 1 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
Follow Advanced Breast Cancer: new trials by email Literature Review of Advanced Breast Cancer trials Research Report on Advanced Breast Cancer
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 |
|---|---|---|---|---|---|---|
| T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd Trastuzumab deruxtecan, Trastuzumab, Pertuzumab - Advanced Breast Cancer, Metastatic Breast Cancer | Phase 3 | Recruiting | Daiichi Sankyo | 200 | 2026-09-18 | 2026-10-16 |
| Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer Utidelone Capsule, Utidelone Injection, Capecitabine - Advanced Breast Cancer | Phase 3 | Not yet recruiting | Beijing Biostar Pharmaceuticals Co., Ltd. | 308 | 2026-08-01 | 2026-07-06 |
| Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment Capivasertib - Breast Cancer, HR-positive Breast Cancer | Phase 3 | Recruiting | Women's Cancer Study Group GmbH | 250 | 2025-11-27 | 2026-08-05 |
| 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 |
| Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. Everolimus, Elacestrant, Placebo - Advanced Breast Cancer, ER-positive Breast Cancer | Phase 3 | Recruiting | MedSIR | 300 | 2024-12-05 | 2026-08-24 |
| 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 | 2026-10-30 |
| 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 |
| Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients CDK 4/6 inhibitors, Endocrine therapy - Metastatic Breast Cancer, Advanced Breast Cancer | Phase 3 | Recruiting | Region Örebro County | 495 | 2024-04-01 | 2024-11-19 |
| 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 |
| Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES) The combination of Dalpiciclib with physician-selected endocrine therapy, Chemotherapy selected by the physician - Advanced Breast Cancer | Phase 3 | Unknown | Peking Union Medical College Hospital | 80 | 2023-05-15 | 2024-03-12 |
| A Study to Evaluate the Efficacy and Safety in Patients With Advanced Breast Cancer Treated With SYHX2011 Compared to Paclitaxel for Injection (Albumin-bound) SYHX2011, Paclitaxel for injection (albumin-bound) - Advanced Breast Cancer | Phase 3 | Unknown | CSPC Ouyi Pharmaceutical Co., Ltd. | 454 | 2023-05-01 | 2023-03-03 |
| A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer ARV-471, Fulvestrant - Advanced Breast Cancer | Phase 3 | Active not recruiting | Pfizer | 624 | 2023-03-03 | 2026-03-18 |
| A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer XZP-3287+ Letrozole/Anastrozole, Placebo + Letrozole/Anastrozole - Advanced Breast Cancer | Phase 3 | Active not recruiting | Xuanzhu Biopharmaceutical Co., Ltd. | 397 | 2022-03-14 | 2025-07-17 |
| This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer. FCN-437c, Letrozole or anastrozole, Goserelin acetate, Placebo, Letrozole or anastrozole, Goserelin acetate - Advanced Breast Cancer, Female Breast Cancer | Phase 3 | Unknown | Ahon Pharmaceutical Co., Ltd. | 434 | 2022-03-02 | 2022-07-06 |
| This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer. FCN-437c,Fulvestrant,Goserelin acetate, Placebo,Fulvestrant,Goserelin acetate - Advanced Breast Cancer, Female Breast Cancer | Phase 3 | Unknown | Ahon Pharmaceutical Co., Ltd. | 312 | 2022-01-18 | 2022-07-05 |
| A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer XZP-3287+Fulvestrant, Placebo + Fulvestrant - Advanced Breast Cancer | Phase 3 | Active not recruiting | Xuanzhu Biopharmaceutical Co., Ltd. | 300 | 2021-11-16 | 2024-05-24 |
| Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in PIK3CA-mutated HER2+ Advanced BC (ALPHABET) Trastuzumab, Alpelisib, Fulvestrant - Advanced Breast Cancer | Phase 3 | Terminated | Spanish Breast Cancer Research Group | 27 | 2021-09-14 | 2026-10-15 |
| A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer MRG002, Trastuzumab Emtansine for Injection - Advanced Breast Cancer, Metastatic Breast Cancer | Phase 2 / Phase 3 | Unknown | Shanghai Miracogen Inc. | 350 | 2021-06-30 | 2023-03-17 |
| A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer SHR6390 Tablets, Placebo Tablets, Letrozole or Anastrozole Tablets - Advanced Breast Cancer | Phase 3 | Unknown | Jiangsu HengRui Medicine Co., Ltd. | 426 | 2019-07-19 | 2021-06-02 |
| A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer SHR6390, Placebo, Fulvestrant - Advanced Breast Cancer | Phase 3 | Unknown | Jiangsu HengRui Medicine Co., Ltd. | 357 | 2019-06-13 | 2021-06-03 |
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Breast Neoplasms (12) · Neoplasm Metastasis (3) · Breast Diseases (1) · Disease Progression (1) · Multiple Endocrine Neoplasia Type 1 (1) · Neoplasms (1) · Neoplasms by Site (1)
Neoplasms (12) · Skin Diseases (12) · Skin and Connective Tissue Diseases (12) · Breast Diseases (11) · Neoplasms by Site (11) · Neoplastic Processes (3) · Pathologic Processes (3) · Pathological Conditions, Signs and Symptoms (3) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Disease Attributes (1) · Endocrine Gland Neoplasms (1) · Endocrine System Diseases (1) · Genetic Diseases, Inborn (1) · Multiple Endocrine Neoplasia (1) · Neoplasms, Multiple Primary (1)
Fulvestrant (11) · Anastrozole (7) · Letrozole (5) · Trastuzumab (3) · exemestane (3) · Capecitabine (2) · Goserelin (2) · Injections (2) · Paclitaxel (2) · Vinorelbine (2) · capivasertib (2) · palbociclib (2) · pertuzumab (2) · ribociclib (2) · AZD5305 (1)
AstraZeneca (3) · Ahon Pharmaceutical Co., Ltd. (2) · Jiangsu HengRui Medicine Co., Ltd. (2) · Xuanzhu Biopharmaceutical Co., Ltd. (2) · Beijing Biostar Pharmaceuticals Co., Ltd. (1) · CSPC Ouyi Pharmaceutical Co., Ltd. (1) · Daiichi Sankyo (1) · Fuda Cancer Hospital, Guangzhou (1) · Fudan University (1) · MedSIR (1) · Novartis Pharmaceuticals (1) · Olema Pharmaceuticals, Inc. (1) · Peking Union Medical College Hospital (1) · Pfizer (1) · Pierre Fabre Medicament (1)
China (16) · Germany (8) · Italy (8) · Spain (8) · Austria (7) · France (7) · Czechia (6) · South Korea (6) · United Kingdom (6) · United States (6) · Australia (5) · Belgium (5) · Brazil (5) · Bulgaria (5) · Canada (5)
Binghe Xu (2) · Anja Welt, Dr. (1) · Antonio Llombart-Cussac, M.D., Ph.D. (1) · Antonios Valachis, Assoc Prof (1) · Guido Hoctin-Boes (1) · Karim Keddad, MD, PhD (1) · Peter Schmid, PHD Dr (1) · Qiang Sun, M.D. (1) · Qingyuan Zhang (1)
PMID 20938664, PMID 23569309, PMID 29860922, PMID 31305131, PMID 31826360, PMID 33769862, PMID 34102253, PMID 34158598, PMID 34737452, PMID 35465733, PMID 35635717, PMID 36800111, PMID 37182538, PMID 37250148, PMID 37653397, PMID 37673211, PMID 38470447, PMID 39072356, PMID 39431459, PMID 39826197, PMID 40454645, PMID 41461598, PMID 41854603, PMID 42224659, PMID 42334791, PMID 42368972
2015 (1), 2017 (1)