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ClinicalTrials.gov 74 recruiting now official registry

Metastatic Breast Cancer clinical trials

74 of 140 indexed Metastatic Breast Cancer trials are currently recruiting.

140 US clinical trials · 74 currently recruiting

Metastatic Breast Cancer is the subject of 140 registered US clinical trials on ClinicalTrials.gov, 74 of them currently open to new participants. 11 are in Phase 3-4 (later-stage) and 99 in Phase 1-2 (earlier-stage). The most active sponsor is Memorial Sloan Kettering Cancer Center, running 12 of these trials.

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
Phase 147Phase 252Phase 310Phase 41

Active & Recent Trials

140 total, page 1 of 3

RECRUITING Phase 3 1,000 participants

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Olema Pharmaceuticals

NCT07085767

RECRUITING Phase 1 930 participants

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

RECRUITING Phase 1 792 participants

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Hoffmann-La Roche

NCT03424005

RECRUITING Phase 1 768 participants

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

RECRUITING NA 625 participants

Comprehensive Outcomes for After Cancer Health

Pack Health

NCT05349227

RECRUITING Phase 3 540 participants

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

RECRUITING Phase 3 510 participants

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Olema Pharmaceuticals

NCT06016738

RECRUITING Phase 3 500 participants

The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

American Society of Clinical Oncology

NCT06377852

RECRUITING Phase 3 500 participants

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

RECRUITING Phase 1 435 participants

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Stemline Therapeutics

NCT05563220

RECRUITING Phase 3 404 participants

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

BriaCell Therapeutics Corporation

NCT06072612

RECRUITING NA 400 participants

Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer

Massachusetts General Hospital

NCT06795529

RECRUITING Phase 1 392 participants

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

NCT06625775

RECRUITING Phase 1 380 participants

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

RECRUITING Phase 2 357 participants

TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

Ana C Garrido-Castro, MD

NCT06533826

RECRUITING Phase 1 300 participants

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

BeiGene

NCT06120283

RECRUITING Phase 2 297 participants

PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

Kristina A. Fanucci

NCT07222215

RECRUITING Phase 3 230 participants

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

RECRUITING NA 214 participants

Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

Brigham and Women's Hospital

NCT04030507

RECRUITING Phase 2 201 participants

A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT06099769

RECRUITING NA 200 participants

The COMPASSION Study

Dana-Farber Cancer Institute

NCT06507930

RECRUITING Phase 1 190 participants

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

Olema Pharmaceuticals

NCT05508906

RECRUITING Phase 1 180 participants

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

Olema Pharmaceuticals

NCT06784193

RECRUITING NA 176 participants

Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer

Medical College of Wisconsin

NCT03824145

RECRUITING Phase 2 174 participants

Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer

Northwestern University

NCT06062498

RECRUITING Phase 2 172 participants

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

Seagen, a wholly owned subsidiary of Pfizer

NCT06157892

RECRUITING Phase 2 168 participants

SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers

Kathy Miller

NCT05846789

RECRUITING Phase 2 162 participants

A Study of Surgery and Radiotherapy in People With Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT07053085

RECRUITING Phase 2 150 participants

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

Puma Biotechnology

NCT06369285

RECRUITING Phase 2 145 participants

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

RECRUITING Phase 1 124 participants

PRE-I-SPY Phase I/Ib Oncology Platform Program

QuantumLeap Healthcare Collaborative

NCT05868226

RECRUITING Phase 2 120 participants

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

Merck Sharp & Dohme

NCT06428396

RECRUITING NA 120 participants

Promoting Resilience in Women With Breast Cancer (PRISM -MBC)

UNC Lineberger Comprehensive Cancer Center

NCT06855654

RECRUITING Phase 1 120 participants

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

RECRUITING Phase 2 120 participants

Scalp Cooling in MBC

Dana-Farber Cancer Institute

NCT04986579

RECRUITING Phase 1 112 participants

A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer

Edgewood Oncology

NCT04872166

RECRUITING 100 participants

DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients

Mayo Clinic

NCT06388122

RECRUITING 100 participants

Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer

University of California, San Francisco

NCT06774027

RECRUITING Phase 1 96 participants

Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer

Boundless Bio

NCT07408089

RECRUITING Phase 1 95 participants

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

RECRUITING Phase 2 80 participants

Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu

University of Utah

NCT07203378

RECRUITING Phase 2 75 participants

Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC

Reshma L. Mahtani, D.O.

NCT06263543

RECRUITING Phase 1 69 participants

Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)

Minerva Biotechnologies Corporation

NCT04020575

RECRUITING NA 67 participants

Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer

Icahn School of Medicine at Mount Sinai

NCT06405828

RECRUITING NA 65 participants

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer

Washington University School of Medicine

NCT05977036

RECRUITING Phase 2 64 participants

Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort

Sonya Reid

NCT05693766

RECRUITING Phase 1 61 participants

Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer

Phoenix Molecular Designs

NCT04115306

RECRUITING Phase 1 52 participants

Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

SynDevRx

NCT05455619

RECRUITING NA 50 participants

Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise

UNC Lineberger Comprehensive Cancer Center

NCT07313306

RECRUITING Phase 1 49 participants

A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT06110793

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Phase Distribution

PhaseTrial count
Phase 1 47
Phase 2 52
Phase 3 10
Phase 4 1

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Metastatic Breast Cancer Trial Landscape

140 indexed Metastatic Breast Cancer studies · 74 recruiting (53%).

Phase mix: 11 late (III/IV) vs 99 early (I/II).

Top sponsor: Memorial Sloan Kettering Cancer Center (12 trials), 9 others listed. 50 shown below, recruiting first.

How to read this condition's trial landscape

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.

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.

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.

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.

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.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.