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ClinicalTrials.gov 5 recruiting now early-phase tilt

Stage IV Breast Cancer: early-phase trial registry

5 of 31 indexed Stage IV Breast Cancer trials are currently recruiting, with more weight in Phase 1-2.

Corpus placement: #495 of 28,707 conditions by registered trial count.

31 US clinical trials · 5 currently recruiting · #495 of 28,707 conditions by registered trial count

Stage IV Breast Cancer: 31 US clinical trials tracked, 5 recruiting.

Stage IV Breast Cancer is the subject of 31 registered US clinical trials on ClinicalTrials.gov, 5 of them currently open to new participants. 2 are in Phase 3-4 (later-stage) and 23 in Phase 1-2 (earlier-stage). The most active sponsor is National Cancer Institute (NCI), running 7 of these trials.

Enrollment posture brief

Registry condition stage-iv-breast-cancer

OPEN 5 | RECR 16% | LATE 2 | EARLY 23 | RANK #495 | SPON 7

Nearest open-share peer: Dental Caries (16% recruiting · 31 trials)

Alcohol Use Disorder71%Chronic Graft Versus Host Di48.4%Anaplastic Astrocytoma41.9%Aortic Valve Stenosis41.9%Stage IV Breast Cancer (this)16%
Open-enrollment share among volume-matched conditions near Stage IV Breast Cancer

Stage IV Breast Cancer lists 5 open slots (16% of 31 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →

Key findings

What ClinicalTrials.gov does not surface for Stage IV Breast Cancer on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.

  1. Stage IV Breast Cancer is recruiting below its size-band peers.

    5 of 31 indexed trials (16.1%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.

  2. One sponsor concentrates Stage IV Breast Cancer research.

    National Cancer Institute (NCI) accounts for 7 of 31 trials (22.6%). 15 distinct sponsors appear on at least one study for this condition label.

  3. Most Stage IV Breast Cancer trials plan to enrol fewer than 100 people.

    Median target enrolment is 30 among the 31 trials that report a genuine target (sentinel values excluded). 27 of those (87.1%) plan for fewer than 100 participants.

  4. Stage IV Breast Cancer research is mostly interventional.

    31 interventional and 0 observational studies make up this index (100% interventional). Study type is sponsor-reported on ClinicalTrials.gov.

Phase 114Phase 29Phase 32

Open and recent trials

31 total, page 1 of 1

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

Named interventions

Most-linked intervention names on Stage IV Breast Cancer records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.

laboratory biomarker analysis Other
10 trials
Laboratory Biomarker Analysis Other
8 trials
Paclitaxel Drug
5 trials
trastuzumab Biological
4 trials
positron emission tomography Procedure
3 trials
pharmacological study Other
3 trials
enzyme-linked immunosorbent assay Other
2 trials
Pharmacological Study Other
2 trials

US sites by state

Facility locations filed on Stage IV Breast Cancer trials. A trial with sites in several states counts in each.

California 8 trials
Washington 6 trials
Massachusetts 6 trials
Texas 4 trials
Illinois 4 trials
Tennessee 3 trials
Pennsylvania 2 trials
New York 2 trials

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

What to do with this Stage IV Breast Cancer page

31 registered trials, 5 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This Stage IV Breast Cancer condition card totals 31 registered trials; most-linked intervention laboratory biomarker analysis; top US site state California. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.