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ClinicalTrials.gov 74 recruiting now official registry

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

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 Francis

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

RECRUITING NA 45 participants

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy

Mayo Clinic

NCT06055881

RECRUITING Phase 1 42 participants

HER-2 B Cell Peptide Vaccine

Pravin T.P Kaumaya

NCT06414733

RECRUITING Phase 1 41 participants

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Weill Medical College of Cornell University

NCT03449238

RECRUITING NA 40 participants

Adaptation of a Values Assessment Tool

UNC Lineberger Comprehensive Cancer Center

NCT07068477

RECRUITING Phase 2 40 participants

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

RECRUITING Phase 2 40 participants

Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer

University of Alabama at Birmingham

NCT06105684

RECRUITING Phase 2 36 participants

STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)

Dartmouth-Hitchcock Medical Center

NCT05716516

RECRUITING Phase 2 36 participants

Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)

The Methodist Hospital Research Institute

NCT05660083

RECRUITING Phase 2 35 participants

Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer

Mayo Clinic

NCT06525766

RECRUITING Phase 1 34 participants

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

University of Utah

NCT04315233

RECRUITING Phase 2 34 participants

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

RECRUITING Phase 1 30 participants

CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer

University of Texas Southwestern Medical Center

NCT05029999

RECRUITING Phase 1 30 participants

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT06246968

RECRUITING 30 participants

A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT06557148

RECRUITING Phase 1 28 participants

A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT06678269

RECRUITING Phase 2 26 participants

Definitive Radiation for High-Risk Spine Metastases

Stony Brook University

NCT06165419

RECRUITING Phase 2 20 participants

Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer

University of California, Irvine

NCT05524584

RECRUITING Phase 2 16 participants

Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis

Wake Forest University Health Sciences

NCT02422641

RECRUITING Phase 2 15 participants

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT06409390

RECRUITING 15 participants

Evaluation of the Acceptability, Appropriateness, and Feasibility/Usability of a Metastatic Breast-cancer Specific Prognostic Calculator Among Clinicians

UNC Lineberger Comprehensive Cancer Center

NCT05440929

RECRUITING Phase 2 15 participants

Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer

University of Louisville

NCT04990921

RECRUITING Phase 2 13 participants

Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

University of Wisconsin, Madison

NCT04573231

RECRUITING 12 participants

Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

University of California, San Francis

NCT05964504

RECRUITING Phase 1 6 participants

Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Mary D Chamberlin

NCT05900895

ACTIVE NOT RECRUITING 7,933 participants

Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United States

Boehringer Ingelheim

NCT07342309

ACTIVE NOT RECRUITING Phase 3 541 participants

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

DualityBio

NCT06018337

ACTIVE NOT RECRUITING Phase 1 500 participants

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

Eli Lilly and Company

NCT04188548

ACTIVE NOT RECRUITING Phase 3 456 participants

Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype

SOLTI Breast Cancer Research Group

NCT05207709

ACTIVE NOT RECRUITING Phase 1 245 participants

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

AstraZeneca

NCT04538742

ACTIVE NOT RECRUITING Phase 2 234 participants

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Eli Lilly and Company

NCT02747004

ACTIVE NOT RECRUITING Phase 2 220 participants

Palbociclib After CDK and Endocrine Therapy (PACE)

Dana-Farber Cancer Institute

NCT03147287

ACTIVE NOT RECRUITING NA 200 participants

Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

NCT02965755

ACTIVE NOT RECRUITING Phase 2 154 participants

PhII ICb With/Without Erbitux in MBC Pts

US Oncology Research

NCT00248287

ACTIVE NOT RECRUITING Phase 1 138 participants

A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

AstraZeneca

NCT04556773

ACTIVE NOT RECRUITING Phase 4 134 participants

Roll-over Study to Allow Continued Access to Ribociclib

Novartis Pharmaceuticals

NCT05161195

ACTIVE NOT RECRUITING Phase 1 125 participants

A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors

Sapience Therapeutics

NCT04478279

ACTIVE NOT RECRUITING Phase 2 114 participants

Olaparib In Metastatic Breast Cancer

Beth Israel Deaconess Medical Center

NCT03344965

ACTIVE NOT RECRUITING NA 110 participants

Couples' QOL in Metastatic Breast Cancer

Fox Chase Cancer Center

NCT05636943

ACTIVE NOT RECRUITING Phase 2 110 participants

Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC

Ana C Garrido-Castro, MD

NCT04448886

ACTIVE NOT RECRUITING Phase 2 82 participants

STOP-HER2: Stopping Trastuzumab in HER2+ MBC

Dana-Farber Cancer Institute

NCT05721248

ACTIVE NOT RECRUITING 78 participants

Assessing the Time Demands of Cancer

Masonic Cancer Center, University of Minnesota

NCT05708703

ACTIVE NOT RECRUITING 65 participants

ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)

Menarini Silicon Biosystems

NCT05662345

ACTIVE NOT RECRUITING Phase 2 61 participants

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

Stemline Therapeutics

NCT05596409

ACTIVE NOT RECRUITING Phase 2 60 participants

Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

NCT02738866

ACTIVE NOT RECRUITING Phase 1 50 participants

Onvansertib + Paclitaxel In TNBC

Antonio Giordano, MD

NCT05383196

ACTIVE NOT RECRUITING Phase 1 46 participants

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

University of Alabama at Birmingham

NCT03368729

ACTIVE NOT RECRUITING Phase 1 30 participants

Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness

University of Maryland, Baltimore

NCT05968144

ACTIVE NOT RECRUITING Phase 2 24 participants

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

ACTIVE NOT RECRUITING Phase 1 22 participants

Her2-BATS and Pembrolizumab in Metastatic Breast Cancer

University of Virginia

NCT03272334

ACTIVE NOT RECRUITING Phase 1 20 participants

[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer

University of Pennsylvania

NCT02608216

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

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.

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.

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