Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.
Metastatic Breast Cancer clinical trials
Every US clinical trial registered for Metastatic Breast Cancer — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.
140 US clinical trials · 74 currently recruiting
The research picture
Metastatic Breast Cancer has 140 registered US clinical trials, 74 of them open to new participants right now — about 53% of the total.
- 74
- recruiting participants now
- 53%
- of trials open to enrollment
- 11
- in Phase 3–4 (later-stage)
- 12
- top sponsor: Memorial Sloan Kettering Cancer Center
Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.
Active & Recent Trials
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Olema Pharmaceuticals
NCT07085767
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
Relay Therapeutics
NCT05216432
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Hoffmann-La Roche
NCT03424005
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Boehringer Ingelheim
NCT06324357
Comprehensive Outcomes for After Cancer Health
Pack Health
NCT05349227
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
Relay Therapeutics
NCT06982521
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Olema Pharmaceuticals
NCT06016738
The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
American Society of Clinical Oncology
NCT06377852
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
Sermonix Pharmaceuticals
NCT05696626
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Stemline Therapeutics
NCT05563220
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
BriaCell Therapeutics Corporation
NCT06072612
Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
Massachusetts General Hospital
NCT06795529
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
NCT06625775
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
BioNTech SE
NCT06827236
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Ana C Garrido-Castro, MD
NCT06533826
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
BeiGene
NCT06120283
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
Kristina A. Fanucci
NCT07222215
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Hoffmann-La Roche
NCT05894239
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
Brigham and Women's Hospital
NCT04030507
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT06099769
The COMPASSION Study
Dana-Farber Cancer Institute
NCT06507930
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Olema Pharmaceuticals
NCT05508906
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Olema Pharmaceuticals
NCT06784193
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
Medical College of Wisconsin
NCT03824145
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Northwestern University
NCT06062498
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
Seagen, a wholly owned subsidiary of Pfizer
NCT06157892
SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers
Kathy Miller
NCT05846789
A Study of Surgery and Radiotherapy in People With Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT07053085
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Puma Biotechnology
NCT06369285
Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease
Memorial Sloan Kettering Cancer Center
NCT03808337
PRE-I-SPY Phase I/Ib Oncology Platform Program
QuantumLeap Healthcare Collaborative
NCT05868226
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
Merck Sharp & Dohme
NCT06428396
Promoting Resilience in Women With Breast Cancer (PRISM -MBC)
UNC Lineberger Comprehensive Cancer Center
NCT06855654
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
BeOne Medicines
NCT06756932
Scalp Cooling in MBC
Dana-Farber Cancer Institute
NCT04986579
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
Edgewood Oncology
NCT04872166
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients
Mayo Clinic
NCT06388122
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
University of California, San Francis
NCT06774027
Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
Boundless Bio
NCT07408089
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
Ellipses Pharma
NCT05573126
Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
University of Utah
NCT07203378
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
Reshma L. Mahtani, D.O.
NCT06263543
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
Minerva Biotechnologies Corporation
NCT04020575
Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
Icahn School of Medicine at Mount Sinai
NCT06405828
BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
Washington University School of Medicine
NCT05977036
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Sonya Reid
NCT05693766
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
Phoenix Molecular Designs
NCT04115306
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
SynDevRx
NCT05455619
Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise
UNC Lineberger Comprehensive Cancer Center
NCT07313306
A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT06110793
Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy
Mayo Clinic
NCT06055881
HER-2 B Cell Peptide Vaccine
Pravin T.P Kaumaya
NCT06414733
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
Weill Medical College of Cornell University
NCT03449238
Adaptation of a Values Assessment Tool
UNC Lineberger Comprehensive Cancer Center
NCT07068477
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT05534438
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
University of Alabama at Birmingham
NCT06105684
STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)
Dartmouth-Hitchcock Medical Center
NCT05716516
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
The Methodist Hospital Research Institute
NCT05660083
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
Mayo Clinic
NCT06525766
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
University of Utah
NCT04315233
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT04683679
CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
University of Texas Southwestern Medical Center
NCT05029999
A Study of Pembrolizumab and Cryoablation in People With Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT06246968
A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT06557148
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT06678269
Definitive Radiation for High-Risk Spine Metastases
Stony Brook University
NCT06165419
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
University of California, Irvine
NCT05524584
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Wake Forest University Health Sciences
NCT02422641
Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
NCT06409390
Evaluation of the Acceptability, Appropriateness, and Feasibility/Usability of a Metastatic Breast-cancer Specific Prognostic Calculator Among Clinicians
UNC Lineberger Comprehensive Cancer Center
NCT05440929
Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer
University of Louisville
NCT04990921
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
University of Wisconsin, Madison
NCT04573231
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
University of California, San Francis
NCT05964504
Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
Mary D Chamberlin
NCT05900895
Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United States
Boehringer Ingelheim
NCT07342309
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
DualityBio
NCT06018337
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer
Eli Lilly and Company
NCT04188548
Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
SOLTI Breast Cancer Research Group
NCT05207709
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
AstraZeneca
NCT04538742
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
Eli Lilly and Company
NCT02747004
Palbociclib After CDK and Endocrine Therapy (PACE)
Dana-Farber Cancer Institute
NCT03147287
Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
NCT02965755
PhII ICb With/Without Erbitux in MBC Pts
US Oncology Research
NCT00248287
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
AstraZeneca
NCT04556773
Roll-over Study to Allow Continued Access to Ribociclib
Novartis Pharmaceuticals
NCT05161195
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
Sapience Therapeutics
NCT04478279
Olaparib In Metastatic Breast Cancer
Beth Israel Deaconess Medical Center
NCT03344965
Couples' QOL in Metastatic Breast Cancer
Fox Chase Cancer Center
NCT05636943
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
Ana C Garrido-Castro, MD
NCT04448886
STOP-HER2: Stopping Trastuzumab in HER2+ MBC
Dana-Farber Cancer Institute
NCT05721248
Assessing the Time Demands of Cancer
Masonic Cancer Center, University of Minnesota
NCT05708703
ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)
Menarini Silicon Biosystems
NCT05662345
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
Stemline Therapeutics
NCT05596409
Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
NCT02738866
Onvansertib + Paclitaxel In TNBC
Antonio Giordano, MD
NCT05383196
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
University of Alabama at Birmingham
NCT03368729
Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness
University of Maryland, Baltimore
NCT05968144
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer
University of Miami
NCT05826964
Her2-BATS and Pembrolizumab in Metastatic Breast Cancer
University of Virginia
NCT03272334
[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer
University of Pennsylvania
NCT02608216
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 47 |
| Phase 2 | 52 |
| Phase 3 | 10 |
| Phase 4 | 1 |
Top Sponsors
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Reading the Metastatic Breast Cancer Trial Landscape
ClinicalTrials.gov lists 140 US studies indexed under Metastatic Breast Cancer, and 74 of those are currently open to recruitment — roughly 53% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.
The phase distribution for Metastatic Breast Cancer shows 11 late-stage studies (Phase 3 and Phase 4 combined) alongside 99 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.
Top sponsor activity for Metastatic Breast Cancer is led by Memorial Sloan Kettering Cancer Center with 12 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 100 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.
Frequently Asked Questions
How many clinical trials are there for Metastatic Breast Cancer?
PlainTrial tracks 140 US clinical trials for Metastatic Breast Cancer, of which 74 are currently recruiting participants. Data sourced from ClinicalTrials.gov.
How do I find a recruiting trial for Metastatic Breast Cancer?
Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.
Is this data current?
Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.
Related
Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.
Read our methodology — how this data is sourced, computed, and verified.
Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.