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triple negative breast cancer

Total Trials
24
Recruiting Now
24
Trial Phases
Phase 1, Phase 3, Phase 2

Cancer clinical trials represent the largest single category of recruiting studies worldwide, encompassing everything from early-phase safety studies of novel oncology drugs to large Phase 3 comparisons against current standard-of-care chemotherapy regimens. The field has accelerated dramatically with the rise of immunotherapy, targeted therapies, and CAR-T cell treatments that have transformed outcomes for previously untreatable malignancies.

Trials include checkpoint inhibitors (PD-1/PD-L1 agents), KRAS inhibitors, ADC (antibody-drug conjugates), combination chemotherapy regimens, radiation protocols, and surgical technique comparisons. Many trials stratify by biomarker status (PD-L1 expression, TMB, MSI-H) to identify patients most likely to benefit.

The NCI, pharmaceutical sponsors, and academic cancer centers collectively fund thousands of oncology trials annually across every cancer type.

Frequently Asked Questions — triple negative breast cancer Clinical Trials

How many clinical trials are currently recruiting for triple negative breast cancer?
ClinicalMetric currently tracks 24 actively recruiting clinical trials for triple negative breast cancer, sourced in real time from ClinicalTrials.gov. The total number of registered studies—including those not yet enrolling or in active follow-up—is 24. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for triple negative breast cancer?
triple negative breast cancer research spans Phase 1 (11 trials), Phase 2 (8 trials), Phase 3 (4 trials). Phase 1 studies evaluate safety and dosing in small groups, Phase 2 studies assess preliminary efficacy in 100–300 participants, and Phase 3 trials compare the new treatment against the standard of care in 300–3,000+ patients. Phase 4 post-approval studies monitor long-term outcomes in real-world populations.
How do I find out if I qualify for a triple negative breast cancer clinical trial?
Eligibility criteria for triple negative breast cancer trials vary by study and typically specify age range, disease stage or severity, prior treatment history, and specific diagnostic or laboratory parameters. Each listing on ClinicalMetric links to the full protocol on ClinicalTrials.gov, where inclusion and exclusion criteria are documented. Contact the sponsoring site's research coordinator directly to confirm your eligibility—your treating physician or specialist can also help identify the most appropriate trial based on your medical history and current treatment status.
Trial Phases
Phase 1
11
Phase 2
8
Phase 3
4
Top Sponsors
H. Lee Moffitt Cancer Center and Research Institute 2 trials
AbbVie 1 trial
UNICANCER 1 trial
Sichuan Baili Pharmaceutical Co., Ltd. 1 trial
Gilead Sciences 1 trial

Recruiting Clinical Trials

NCT05005403 Phase 1
Recruiting

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

Enrollment
694 pts
Location
United States, Canad...
Sponsor
AbbVie
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NCT05552001 Phase 3
Recruiting

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

Enrollment
96 pts
Location
France
Sponsor
UNICANCER
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NCT06471205 Phase 2
Recruiting

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

Enrollment
52 pts
Location
China
Sponsor
Sichuan Baili Pharmaceutical C...
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NCT06926920 Phase 1, Phase 2
Recruiting

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

Enrollment
100 pts
Location
United States, Austr...
Sponsor
Gilead Sciences
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NCT05115474
Recruiting

Study of Screening Brain MRIs in Stage IV Breast Cancer

Enrollment
170 pts
Location
United States
Sponsor
H. Lee Moffitt Cancer Center a...
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NCT04947189 Phase 1, Phase 2
Recruiting

Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer

Enrollment
65 pts
Location
Australia
Sponsor
St Vincent's Hospital, Sydney
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NCT06631092 Phase 1, Phase 2
Recruiting

Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer

Enrollment
12 pts
Location
Germany
Sponsor
NEC Bio B.V
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NCT06371274
Recruiting

A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.

Enrollment
29 pts
Location
China
Sponsor
First Affiliated Hospital of Z...
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NCT05916755
Recruiting

Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform

Enrollment
100 pts
Location
Spain
Sponsor
Vall d'Hebron Institute of Onc...
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NCT06245889 Phase 2
Recruiting

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Enrollment
30 pts
Location
United States
Sponsor
Sidney Kimmel Comprehensive Ca...
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NCT06328465
Recruiting

fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases

Enrollment
145 pts
Location
Italy
Sponsor
European Institute of Oncology
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NCT06889688 Phase 3
Recruiting

Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer

Enrollment
246 pts
Location
China
Sponsor
Sun Yat-Sen Memorial Hospital ...
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NCT05722795
Recruiting

Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer (I-CONIC)

Enrollment
40 pts
Location
Sweden
Sponsor
Vastra Gotaland Region
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NCT06586047 EARLY_Phase 1
Recruiting

Breast Cancer PSMA PET

Enrollment
30 pts
Location
United States
Sponsor
Ahmad Shariftabrizi
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NCT05504707 Phase 1
Recruiting

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

Enrollment
30 pts
Location
United States
Sponsor
H. Lee Moffitt Cancer Center a...
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NCT06279364 Phase 3
Recruiting

A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Enrollment
524 pts
Location
China
Sponsor
Sichuan Kelun-Biotech Biopharm...
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NCT06692725
Recruiting

De-escalation of Neoadjuvant Chemotherapy Regimens With Immunotherapy Among TNBC

Enrollment
380 pts
Location
China
Sponsor
Peking University People's Hos...
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NCT06134375 Phase 1, Phase 2
Recruiting

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

Enrollment
204 pts
Location
United States
Sponsor
Dartmouth-Hitchcock Medical Ce...
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NCT06908928 Phase 1
Recruiting

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

Enrollment
52 pts
Location
United States
Sponsor
Mabwell (Shanghai) Bioscience ...
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NCT06451497 Phase 1
Recruiting

This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors

Enrollment
100 pts
Location
United States
Sponsor
Zumutor Biologics Inc.
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NCT05955105 Phase 1, Phase 2
Recruiting

A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies

Enrollment
200 pts
Location
China
Sponsor
Innolake Biopharm
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NCT04722978 Phase 3
Recruiting

Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer

Enrollment
228 pts
Location
China
Sponsor
Sun Yat-Sen University Cancer ...
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NCT05485766 Phase 2
Recruiting

Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

Enrollment
23 pts
Location
Japan
Sponsor
Okayama University
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NCT05983432 Phase 1
Recruiting

Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

Enrollment
470 pts
Location
United States, Franc...
Sponsor
SystImmune Inc.
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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology