6 terminated, 6 withdrawn, 5 active not recruiting, 4 recruiting. 25 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 25 | Terminated 6, Withdrawn 6, Active not recruiting 5, Recruiting 4, Completed 3, Suspended 1 |
| Phase 2 | 5 | Terminated 2, Withdrawn 2, Recruiting 1 |
Follow Metastatic Breast Carcinoma: new trials by email Literature Review of Metastatic Breast Carcinoma trials Research Report on Metastatic Breast Carcinoma
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 |
|---|---|---|---|---|---|---|
| Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer Biopsy Procedure, Biospecimen Collection, Echocardiography Test - Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8 | Phase 1 | Recruiting | National Cancer Institute (NCI) | 36 | 2026-10-06 | 2026-10-16 |
| Testing the Safety of the Anti-cancer Drug, Sn-117m-DTPA, for Advanced Cancers That Have Spread to Bones Biospecimen Collection, Bone Scan, Computed Tomography - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma | Phase 1 | Withdrawn | National Cancer Institute (NCI) | 2026-10-01 | 2026-08-28 | |
| [18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer Best Practice, Biopsy of Breast, Computed Tomography - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma | Phase 1 / Phase 2 | Recruiting | University of Washington | 22 | 2026-02-26 | 2026-05-19 |
| Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors Abemaciclib, BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure - Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8 | Phase 1 | Recruiting | National Cancer Institute (NCI) | 45 | 2023-08-10 | 2026-07-31 |
| In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors Anti-CD40 Agonist Monoclonal Antibody CDX-1140, Poly ICLC, Radiation Therapy - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma | Phase 1 | Active not recruiting | University of Southern California | 14 | 2023-01-09 | 2026-06-18 |
| Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax Atezolizumab, Cabozantinib S-malate, Nab-paclitaxel - Advanced Breast Carcinoma, Advanced Endometrial Carcinoma | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 43 | 2022-04-29 | 2026-07-16 |
| Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer Dostarlimab, Niraparib, Biopsy - Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8 | Phase 1 | Active not recruiting | University of Washington | 18 | 2021-10-18 | 2026-08-20 |
| Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial Biopsy Procedure, Biospecimen Collection, Ceralasertib - Advanced Breast Carcinoma, Advanced Colon Carcinoma | Phase 1 | Active not recruiting | National Cancer Institute (NCI) | 51 | 2021-08-09 | 2026-09-04 |
| Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer Copanlisib, Pertuzumab, Trastuzumab - Anatomic Stage IV Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma | Phase 1 / Phase 2 | Terminated | National Cancer Institute (NCI) | 2 | 2021-05-20 | 2025-10-01 |
| Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer Abexinostat Tosylate, Fulvestrant, Palbociclib - Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8 | Phase 1 | Withdrawn | Pamela Munster | 2021-03-31 | 2021-05-18 | |
| Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial Bintrafusp Alfa, Immunocytokine NHS-IL12, Radiation Therapy - Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Adenocarcinoma | Phase 1 | Withdrawn | M.D. Anderson Cancer Center | 2021-03-07 | 2023-12-27 | |
| Breast Cancer Vaccine in Combination With Pembrolizumab for Treatment of Persistent, Recurrent, or Metastatic Breast Cancer Cyclophosphamide, Allogeneic GM-CSF-secreting Breast Cancer Vaccine SV-BR-1-GM, Pembrolizumab - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma | Phase 1 / Phase 2 | Withdrawn | Thomas Jefferson University | 2020-12-21 | 2025-04-29 | |
| Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors NUV-422 - Glioma, Glioma, Malignant | Phase 1 | Terminated | Nuvation Bio Inc. | 74 | 2020-12-08 | 2023-07-14 |
| Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer Abemaciclib, Biopsy Procedure, Biospecimen Collection - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma | Phase 1 | Active not recruiting | National Cancer Institute (NCI) | 24 | 2020-06-17 | 2026-09-08 |
| Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases Abemaciclib, Palbociclib, Quality-of-Life Assessment - Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma | Phase 1 | Withdrawn | Emory University | 2020-06-12 | 2021-10-18 | |
| Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer Alpha-tocopheryloxyacetic Acid, Trastuzumab - Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma | Phase 1 | Suspended | Veana Therapeutics | 24 | 2020-04-08 | 2024-07-10 |
| Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial Abemaciclib, Abiraterone, Afatinib - Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8 | Phase 1 | Terminated | OHSU Knight Cancer Institute | 2 | 2020-04-01 | 2024-03-04 |
| Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer Alpelisib, Enzalutamide - Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8 | Phase 1 | Completed | M.D. Anderson Cancer Center | 18 | 2019-06-07 | 2024-10-10 |
| A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer Copanlisib, Fulvestrant - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma | Phase 1 / Phase 2 | Withdrawn | National Cancer Institute (NCI) | 2019-02-13 | 2023-09-25 | |
| PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Docetaxel, Laboratory Biomarker Analysis, Pharmacological Study - Advanced Breast Carcinoma, Advanced Malignant Solid Neoplasm | Phase 1 | Completed | National Cancer Institute (NCI) | 23 | 2018-09-24 | 2026-04-29 |
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Breast Neoplasms (25) · Neoplasm Metastasis (8) · Prostatic Neoplasms (4) · Triple Negative Breast Neoplasms (4) · Fallopian Tube Neoplasms (3) · Ovarian Neoplasms (3) · Brain Neoplasms (2) · Endometrial Neoplasms (2) · Hodgkin Disease (2) · Lymphoma, Non-Hodgkin (2) · Pancreatic Neoplasms (2) · Anemia (1) · Blast Crisis (1) · Bone Neoplasms (1) · Carcinoma, Basal Cell (1)
Breast Diseases (25) · Neoplasms (25) · Neoplasms by Site (25) · Skin Diseases (25) · Skin and Connective Tissue Diseases (25) · Genital Diseases (8) · Neoplastic Processes (8) · Pathologic Processes (8) · Pathological Conditions, Signs and Symptoms (8) · Urogenital Diseases (8) · Urogenital Neoplasms (8) · Neoplasms by Histologic Type (7) · Male Urogenital Diseases (5) · Digestive System Diseases (4) · Digestive System Neoplasms (4)
Specimen Handling (6) · Biopsy (5) · Magnetic Resonance Spectroscopy (5) · copanlisib (5) · Ogivri (4) · Ontruzant (4) · PF-05280014 (4) · Taxes (4) · Trastuzumab (4) · abemaciclib (4) · pembrolizumab (4) · trastuzumab biosimilar HLX02 (4) · 2C4 antibody (3) · Cyclophosphamide (3) · Fulvestrant (3)
National Cancer Institute (NCI) (10) · M.D. Anderson Cancer Center (5) · University of Washington (2) · Emory University (1) · Mayo Clinic (1) · Nuvation Bio Inc. (1) · OHSU Knight Cancer Institute (1) · Pamela Munster (1) · Thomas Jefferson University (1) · University of Southern California (1) · Veana Therapeutics (1)
United States (21)
Meghan Karuturi (2) · Alison M Schram (1) · Apostolia M Tsimberidou (1) · Cynthia X Ma (1) · Elizabeth C Dees (1) · Elizabeth M. Swisher (1) · Filipa Lynce (1) · Fumito Ito, MD (1) · Grzegorz S. Nowakowski, M.D. (1) · Jennifer Specht, MD (1) · Jia Luo (1) · Jim Zhong (1) · Joseph A Sparano (1) · Kanwal P Raghav (1) · Lara Davis, MD (1)
PMID 36351402, PMID 38152697, PMID 39863139, PMID 40939237, PMID 41116969
UM1CA186688 (2), UM1CA186704 (2), UM1CA186709 (2), UM1CA186712 (2), N01CM62204 (1), P30CA013330 (1), P30CA138292 (1), UM1CA186689 (1), UM1CA186691 (1)