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ClinicalTrials.gov 68 recruiting now official registry

Triple Negative Breast Cancer clinical trials

68 of 119 indexed Triple Negative Breast Cancer trials are currently recruiting.

119 US clinical trials · 68 currently recruiting

Triple Negative Breast Cancer is the subject of 119 registered US clinical trials on ClinicalTrials.gov, 68 of them currently open to new participants. 8 are in Phase 3-4 (later-stage) and 98 in Phase 1-2 (earlier-stage). The most active sponsor is H. Lee Moffitt Cancer Center and Research Institute, running 6 of these trials.

The research picture

Triple Negative Breast Cancer has 119 registered US clinical trials, 68 of them open to new participants right now, about 57% of the total.

68
recruiting participants now
57%
of trials open to enrollment
8
in Phase 3–4 (later-stage)
6
top sponsor: H. Lee Moffitt Cancer Center and Research Institute
Phase 170Phase 228Phase 38

Active & Recent Trials

119 total, page 2 of 3

RECRUITING Phase 1 38 participants

A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors

Hefei TG ImmunoPharma Co.

NCT05746897

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 33 participants

Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Zumutor Biologics

NCT06451497

RECRUITING Phase 1 31 participants

Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

H. Lee Moffitt Cancer Center and Research Institute

NCT06238921

RECRUITING NA 30 participants

TNBC Gut Microbiota During Neoadjuvant Treatment

Scripps Health

NCT06610097

RECRUITING Phase 1 30 participants

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT05504707

RECRUITING Phase 2 30 participants

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

NCT06245889

RECRUITING NA 30 participants

Breast Cancer PSMA PET

Ahmad Shariftabrizi

NCT06586047

RECRUITING Phase 1 30 participants

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT06246968

RECRUITING Early Phase 1 30 participants

Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

Alison Stopeck

NCT06220214

RECRUITING Phase 2 28 participants

Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

M.D. Anderson Cancer Center

NCT06318897

RECRUITING Early Phase 1 20 participants

Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)

University of Alabama at Birmingham

NCT04861077

RECRUITING Phase 1 18 participants

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)

H. Lee Moffitt Cancer Center and Research Institute

NCT05809752

RECRUITING Early Phase 1 16 participants

Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy

H. Lee Moffitt Cancer Center and Research Institute

NCT06435351

RECRUITING Phase 1 15 participants

Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer

Eileen Connolly

NCT02977468

RECRUITING Phase 1 12 participants

Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)

University of Illinois at Chicago

NCT04427293

RECRUITING Phase 2 12 participants

Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients

Providence Health & Services

NCT06353997

RECRUITING Early Phase 1 12 participants

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors

Pure Biologics S.A.

NCT06700070

ACTIVE NOT RECRUITING Phase 3 1,550 participants

Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo

NSABP Foundation

NCT03281954

ACTIVE NOT RECRUITING Phase 1 914 participants

Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

Exelixis

NCT03170960

ACTIVE NOT RECRUITING Phase 1 890 participants

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

Daiichi Sankyo Co.

NCT03401385

ACTIVE NOT RECRUITING 760 participants

Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer

Daiichi Sankyo

NCT07092254

ACTIVE NOT RECRUITING Phase 3 623 participants

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Gilead Sciences

NCT05382299

ACTIVE NOT RECRUITING Phase 3 575 participants

Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC

OBI Pharma

NCT03562637

ACTIVE NOT RECRUITING Phase 3 443 participants

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Gilead Sciences

NCT05382286

ACTIVE NOT RECRUITING Phase 1 302 participants

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

AbbVie

NCT06084481

ACTIVE NOT RECRUITING Phase 1 288 participants

Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

BicycleTx Limited

NCT04180371

ACTIVE NOT RECRUITING Phase 1 134 participants

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations

Atavistik Bio

NCT07038369

ACTIVE NOT RECRUITING Phase 2 120 participants

Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)

Laura M. Spring, MD

NCT04443348

ACTIVE NOT RECRUITING Phase 2 120 participants

Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer

University of Kansas Medical Center

NCT03639948

ACTIVE NOT RECRUITING Phase 2 107 participants

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

Memorial Sloan Kettering Cancer Center

NCT03808662

ACTIVE NOT RECRUITING Phase 1 98 participants

Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.

Novartis Pharmaceuticals

NCT03891953

ACTIVE NOT RECRUITING Phase 2 83 participants

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

BioNTech SE

NCT06449222

ACTIVE NOT RECRUITING Phase 1 78 participants

ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in mTNBC

Filipa Lynce, MD

NCT06351332

ACTIVE NOT RECRUITING Phase 1 67 participants

Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

Immunitas Therapeutics

NCT05565417

ACTIVE NOT RECRUITING Phase 2 67 participants

Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer

City of Hope Medical Center

NCT01525966

ACTIVE NOT RECRUITING Phase 1 63 participants

AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

Adlai Nortye Biopharma Co.

NCT04432857

ACTIVE NOT RECRUITING Phase 2 62 participants

Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer

Rutgers, The State University of New Jersey

NCT02315196

ACTIVE NOT RECRUITING Phase 1 51 participants

Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

Priyanka Sharma

NCT02393794

ACTIVE NOT RECRUITING Phase 2 50 participants

Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT02750358

ACTIVE NOT RECRUITING Phase 1 37 participants

Ribociclib and Bicalutamide in AR+ TNBC

Kari Wisinski

NCT03090165

ACTIVE NOT RECRUITING Phase 2 32 participants

Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer

Massachusetts General Hospital

NCT04837209

ACTIVE NOT RECRUITING Phase 1 29 participants

Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer

Providence Health & Services

NCT02734290

ACTIVE NOT RECRUITING Phase 2 25 participants

INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study

Mridula George, MD

NCT04445844

ACTIVE NOT RECRUITING Phase 1 21 participants

A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

Massachusetts General Hospital

NCT03945721

ACTIVE NOT RECRUITING Phase 1 20 participants

PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer

Massachusetts General Hospital

NCT03362060

ACTIVE NOT RECRUITING Phase 1 15 participants

Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer

Washington University School of Medicine

NCT04331067

ACTIVE NOT RECRUITING 14 participants

Comparison of the Breast Tumor Microenvironment

Columbia University

NCT03165487

ACTIVE NOT RECRUITING Phase 2 13 participants

Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel in Triple Negative Breast Cancer

University of Illinois at Chicago

NCT04083963

ACTIVE NOT RECRUITING Phase 1 6 participants

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

TCR2 Therapeutics

NCT05451849

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Phase Distribution

PhaseTrial count
Phase 1 70
Phase 2 28
Phase 3 8

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

Reading the Triple Negative Breast Cancer Trial Landscape

119 indexed Triple Negative Breast Cancer studies · 68 recruiting (57%).

Phase mix: 8 late (III/IV) vs 98 early (I/II).

Top sponsor: H. Lee Moffitt Cancer Center and Research Institute (6 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 Triple Negative Breast Cancer?

PlainTrial tracks 119 US clinical trials for Triple Negative Breast Cancer, of which 68 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Triple Negative 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.