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ClinicalTrials.gov 5 recruiting now official registry

Stage IV Breast Cancer clinical trials

Every US clinical trial registered for Stage IV Breast Cancer — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

31 US clinical trials · 5 currently recruiting

The research picture

Stage IV Breast Cancer has 31 registered US clinical trials, 5 of them open to new participants right now — about 16% of the total.

5
recruiting participants now
16%
of trials open to enrollment
2
in Phase 3–4 (later-stage)
7
top sponsor: National Cancer Institute (NCI)

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 2 150 participants

Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Laura Huppert, MD, BA

NCT03971409

RECRUITING Phase 2 100 participants

Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer

Northwestern University

NCT03213041

RECRUITING Phase 2 72 participants

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

Dana-Farber Cancer Institute

NCT06439693

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 NA 20 participants

Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

University of Miami

NCT05959291

ACTIVE NOT RECRUITING Phase 3 654 participants

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

Gilead Sciences

NCT05840211

ACTIVE NOT RECRUITING Phase 2 63 participants

Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer

City of Hope Medical Center

NCT01730833

ACTIVE NOT RECRUITING Phase 1 46 participants

BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

Vanderbilt-Ingram Cancer Center

NCT01791478

ACTIVE NOT RECRUITING Phase 1 42 participants

Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer

University of Washington

NCT02157051

ACTIVE NOT RECRUITING NA 18 participants

Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer

City of Hope Medical Center

NCT01093612

ACTIVE NOT RECRUITING NA 10 participants

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

City of Hope Medical Center

NCT02226276

COMPLETED Phase 3 250 participants

Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer

Dana-Farber Cancer Institute

NCT00146549

COMPLETED NA 81 participants

Ask Questions (ASQ):Implementation of a Communication Intervention

Barbara Ann Karmanos Cancer Institute

NCT05025748

COMPLETED Phase 2 37 participants

Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer

National Cancer Institute (NCI)

NCT00006228

COMPLETED Phase 1 35 participants

Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

National Cancer Institute (NCI)

NCT00217399

COMPLETED Phase 2 35 participants

PS-341 in Treating Women With Metastatic Breast Cancer

National Cancer Institute (NCI)

NCT00025584

COMPLETED Phase 1 31 participants

Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

University of Chicago

NCT02046421

COMPLETED Phase 1 31 participants

Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

University of Washington

NCT01922921

COMPLETED Phase 1 31 participants

Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer

National Cancer Institute (NCI)

NCT00100750

COMPLETED Phase 2 30 participants

MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer

Northwestern University

NCT02536794

COMPLETED Phase 1 30 participants

Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer

University of Washington

NCT00331552

COMPLETED Phase 2 30 participants

Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer

Indiana University

NCT00577122

COMPLETED Phase 1 29 participants

Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer

Vanderbilt-Ingram Cancer Center

NCT02672475

COMPLETED Phase 1 24 participants

Decitabine in Treating Patients With Advanced Solid Tumors

National Cancer Institute (NCI)

NCT00030615

COMPLETED Phase 1 23 participants

Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

University of Washington

NCT00791037

COMPLETED Phase 1 22 participants

Veliparib in Combination With Carboplatin and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors

National Cancer Institute (NCI)

NCT01281150

COMPLETED Phase 2 22 participants

Tivantinib in Treating Patients With Recurrent or Metastatic Breast Cancer

National Cancer Institute (NCI)

NCT01575522

COMPLETED Phase 1 18 participants

4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer

George W. Sledge Jr.

NCT03364348

COMPLETED Phase 1 15 participants

ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment

University of Washington

NCT00425672

COMPLETED NA 13 participants

Pilot Study Estradiol Followed by Exemestane Hormone Receptor + Metastatic Breast Cancer

University of Arizona

NCT01385280

COMPLETED NA 8 participants

Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Aromatase Inhibitor Therapy

University of Washington

NCT01153672

Phase Distribution

PhaseTrial count
Phase 1 14
Phase 2 9
Phase 3 2

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

Reading the Stage IV Breast Cancer Trial Landscape

ClinicalTrials.gov lists 31 US studies indexed under Stage IV Breast Cancer, and 5 of those are currently open to recruitment — roughly 16% 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 Stage IV Breast Cancer shows 2 late-stage studies (Phase 3 and Phase 4 combined) alongside 23 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 Stage IV Breast Cancer is led by National Cancer Institute (NCI) with 7 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 31 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 Stage IV Breast Cancer?

PlainTrial tracks 31 US clinical trials for Stage IV Breast Cancer, of which 5 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Stage IV 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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