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ClinicalTrials.gov 64 recruiting now official registry

Triple Negative Breast Cancer clinical trials

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

104 US clinical trials · 64 currently recruiting

The research picture

Triple Negative Breast Cancer has 104 registered US clinical trials, 64 of them open to new participants right now — about 62% of the total.

64
recruiting participants now
62%
of trials open to enrollment
7
in Phase 3–4 (later-stage)
6
top sponsor: H. Lee Moffitt Cancer Center and Research Institute

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 5,000 participants

ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

Persephone Biosciences

NCT04638751

RECRUITING 1,650 participants

A Multicenter Cancer Biospecimen Collection Study

Cofactor Genomics

NCT04510129

RECRUITING Phase 3 1,514 participants

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

Gilead Sciences

NCT05633654

RECRUITING Phase 1 764 participants

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

Genmab

NCT05579366

RECRUITING Phase 3 657 participants

A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients

Jina Pharmaceuticals

NCT03671044

RECRUITING Phase 1 512 participants

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab

AbbVie

NCT05005403

RECRUITING Phase 1 490 participants

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Eli Lilly and Company

NCT06238479

RECRUITING Phase 1 420 participants

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

Eli Lilly and Company

NCT06465069

RECRUITING Phase 1 319 participants

A Study of XMT-1660 in Participants With Solid Tumors

Mersana Therapeutics

NCT05377996

RECRUITING Phase 1 260 participants

A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

Pfizer

NCT07318805

RECRUITING Phase 2 260 participants

Sacituzumab Govitecan In TNBC

Massachusetts General Hospital

NCT04230109

RECRUITING Phase 1 240 participants

A Study of LY4175408 in Participants With Advanced Cancer

Eli Lilly and Company

NCT07046923

RECRUITING Phase 1 220 participants

Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies

Circle Pharma

NCT06577987

RECRUITING NA 214 participants

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

Brigham and Women's Hospital

NCT04030507

RECRUITING Phase 1 204 participants

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

Dartmouth-Hitchcock Medical Center

NCT06134375

RECRUITING Phase 1 200 participants

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer

Volastra Therapeutics

NCT05902988

RECRUITING Phase 2 185 participants

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

Baylor Breast Care Center

NCT05020860

RECRUITING 170 participants

Study of Screening Brain MRIs in Stage IV Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT05115474

RECRUITING Phase 1 168 participants

A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.

OncoNano Medicine

NCT06022029

RECRUITING Phase 2 168 participants

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

Kathy Miller

NCT05846789

RECRUITING Phase 1 162 participants

Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Novartis Pharmaceuticals

NCT06562192

RECRUITING NA 160 participants

Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC

Yale University

NCT07066189

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 2 139 participants

Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC

University of Kansas Medical Center

NCT05645380

RECRUITING Phase 1 124 participants

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

QuantumLeap Healthcare Collaborative

NCT05868226

RECRUITING Phase 1 115 participants

A Beta-only IL-2 ImmunoTherapY Study

Medicenna Therapeutics

NCT05086692

RECRUITING Phase 2 110 participants

Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC

Dana-Farber Cancer Institute

NCT04468061

RECRUITING Phase 1 100 participants

A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

Gilead Sciences

NCT06926920

RECRUITING Phase 1 100 participants

A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors

Apollo Therapeutics

NCT06399757

RECRUITING Phase 1 96 participants

A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

Dren Bio

NCT06999187

RECRUITING Phase 1 90 participants

First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer

Accent Therapeutics

NCT06799065

RECRUITING NA 90 participants

Cardiac Outcomes With Near-Complete Estrogen Deprivation

Duke University

NCT05309655

RECRUITING Phase 2 86 participants

Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT05528133

RECRUITING Phase 1 77 participants

First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies

A&G Pharmaceutical

NCT05627960

RECRUITING Phase 1 73 participants

A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

Compass Therapeutics

NCT06150664

RECRUITING Phase 1 67 participants

Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies

University of California, Irvine

NCT07064018

RECRUITING Phase 1 60 participants

Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies

BioEclipse Therapeutics

NCT04282044

RECRUITING Phase 1 60 participants

A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

AstraZeneca

NCT07115043

RECRUITING Phase 1 52 participants

A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs

Mabwell (Shanghai) Bioscience Co.

NCT06908928

RECRUITING Phase 1 51 participants

ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

ProDa BioTech

NCT06460298

RECRUITING Phase 2 50 participants

Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients

Wake Forest University Health Sciences

NCT04677816

RECRUITING Phase 2 43 participants

Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients

Medical University of South Carolina

NCT06845319

RECRUITING Phase 1 42 participants

Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

UNC Lineberger Comprehensive Cancer Center

NCT06347068

RECRUITING Phase 1 40 participants

MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors

Memgen

NCT05076760

RECRUITING Phase 2 40 participants

Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer

Stanford University

NCT04768426

RECRUITING Phase 2 40 participants

Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)

Dana-Farber Cancer Institute

NCT04434040

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 2 107 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 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 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

COMPLETED Phase 3 902 participants

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

Hoffmann-La Roche

NCT02425891

COMPLETED Phase 1 269 participants

Study of XB002 in Subjects With Solid Tumors (JEWEL-101)

Exelixis

NCT04925284

COMPLETED Phase 1 229 participants

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

Esperas Pharma

NCT02632448

COMPLETED Phase 1 215 participants

NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

NeoImmuneTech

NCT04332653

COMPLETED Phase 1 185 participants

A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands

Novartis Pharmaceuticals

NCT01351103

COMPLETED 68 participants

Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer

Icahn School of Medicine at Mount Sinai

NCT02247037

COMPLETED Phase 1 54 participants

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

Incyte Corporation

NCT04580485

COMPLETED Phase 1 48 participants

Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer

TransThera Sciences (Nanjing)

NCT03654547

COMPLETED Phase 1 48 participants

A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

Merrimack Pharmaceuticals

NCT01451632

COMPLETED Phase 2 40 participants

Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer

UNC Lineberger Comprehensive Cancer Center

NCT02768701

Phase Distribution

PhaseTrial count
Phase 1 63
Phase 2 22
Phase 3 7

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

Reading the Triple Negative Breast Cancer Trial Landscape

ClinicalTrials.gov lists 104 US studies indexed under Triple Negative Breast Cancer, and 64 of those are currently open to recruitment — roughly 62% 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 Triple Negative Breast Cancer shows 7 late-stage studies (Phase 3 and Phase 4 combined) alongside 85 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 Triple Negative Breast Cancer is led by H. Lee Moffitt Cancer Center and Research Institute with 6 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 Triple Negative Breast Cancer?

PlainTrial tracks 104 US clinical trials for Triple Negative Breast Cancer, of which 64 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.

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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