28 recruiting, 14 not yet recruiting, 7 terminated, 6 active not recruiting. 30 Phase 1, 26 Phase 2, 6 Phase 3, 3 Not applicable.
Follow Triple Negative Breast Cancer (TNBC): new trials by email Literature Review of Triple Negative Breast Cancer (TNBC) trials Research Report on Triple Negative Breast Cancer (TNBC)
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs) Carboplatin, Paclitaxcel, Pembrolizumab - Triple Negative Breast Cancer (TNBC), Elevated Tumor-Infiltrating Lymphocytes | Phase 2 | Recruiting | Medical University of South Carolina | 55 | 2027-01-01 | 2026-10-15 |
| A Phase 1, Multicenter Imaging Study of LNTH-2403 in Participants With Locally Advanced or Metastatic Solid Tumors. LNTH-2403 - Imaging, Colorectal Cancer | Phase 1 | Not yet recruiting | Radiopharm Theranostics, Ltd | 16 | 2026-10-30 | 2026-08-12 |
| An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab in First to Third Line BLIS Subtype TNBC SHR- A1811, SHR-A1811+BEV - Breast Cancer, Triple Negative Breast Cancer (TNBC) | Phase 3 | Not yet recruiting | Fudan University | 140 | 2026-10-01 | 2026-06-25 |
| An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus in First to Third Line LAR Subtype TNBC SHR- A1811+ eve, SHR- A1811 - Breast Cancer, Triple Negative Breast Cancer (TNBC) | Phase 3 | Not yet recruiting | Fudan University | 180 | 2026-10-01 | 2026-08-12 |
| A Phase 1a/1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers CT-202 - Triple Negative Breast Cancer (TNBC), Colorectal Cancer | Phase 1 | Recruiting | Context Therapeutics Inc. | 162 | 2026-09-01 | 2026-10-08 |
| A Study of IOV-5001 in Adults With Advanced Solid Tumors IOV-5001 - Advanced Solid Tumors, Non-Small Cell Lung Cancer | Phase 1 / Phase 2 | Not yet recruiting | Iovance Biotherapeutics, Inc. | 106 | 2026-09-01 | 2026-09-15 |
| Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer ITI-5000 mRNA Vaccine, Pembrolizumab, Olaparib - Triple Negative Breast Cancer (TNBC) | Phase 1 | Recruiting | Immunomic Therapeutics, Inc. | 60 | 2026-07-14 | 2026-09-10 |
| A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer RESTORE, Enhanced Usual Care - Triple Negative Breast Cancer (TNBC) | Not applicable | Recruiting | Massachusetts General Hospital | 75 | 2026-07-07 | 2026-09-15 |
| Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer Breast Cancer, Triple Negative Breast Cancer (TNBC) | Not yet recruiting | Federico II University | 186 | 2026-07-01 | 2026-06-23 | |
| A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors SHY-ONC6 - Advanced or Metastatic Solid Tumors, Triple Negative Breast Cancer (TNBC) | Phase 1 | Recruiting | SHY Therapeutics | 30 | 2026-06-24 | 2026-10-22 |
| Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors 68Ga-DFC413, 68Ga-NNS309 - Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC) | Phase 1 | Recruiting | Novartis Pharmaceuticals | 66 | 2026-06-23 | 2026-08-27 |
| Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC) Triple Negative Breast Cancer (TNBC) | Not yet recruiting | Peter MacCallum Cancer Centre, Australia | 75 | 2026-04-08 | 2026-04-14 | |
| Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer Biolosion (oral probiotic compound preparation) - Breast Cancer, Triple Negative Breast Cancer (TNBC) | Phase 2 | Recruiting | Sun Yat-sen University | 192 | 2026-04-01 | 2026-04-01 |
| Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer Neoadjuvant Pembrolizumab, low dose neoadjuvant boost, High dose neoadjuvant boost - Breast Cancer, Triple Negative Breast Cancer (TNBC) | Phase 2 | Recruiting | UNC Lineberger Comprehensive Cancer Center | 32 | 2026-03-17 | 2026-04-27 |
| PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease Datopotamab deruxtecan, Circulating tumor DNA (ctDNA) testing - Breast Cancer, Residual Disease | Phase 2 | Recruiting | UNC Lineberger Comprehensive Cancer Center | 78 | 2026-02-26 | 2026-04-22 |
| QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer Immunotherapy combined with chemotherapy - Triple Negative Breast Cancer (TNBC) | Phase 2 | Recruiting | Affiliated Hospital of Nantong University | 30 | 2026-02-25 | 2026-03-02 |
| Adjuvant Intensification for LAR Everolimus 10 mg daily - Breast Cancer Females, Triple Negative Breast Cancer (TNBC) | Phase 3 | Not yet recruiting | Fudan University | 904 | 2026-02-01 | 2026-02-12 |
| The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab Combined With Olaparib and Paclitaxel Iparomlimab and tuvonralimab combined with olaparib and paclitaxel - Triple Negative Breast Cancer (TNBC) | Not applicable | Not yet recruiting | Harbin Medical University | 20 | 2025-12-30 | 2025-09-23 |
| A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4 RNDO-564, Pembrolizumab - Non Small Cell Lung Cancer, Cervical Cancer | Phase 1 | Enrolling by invitation | Rondo Therapeutics | 149 | 2025-11-17 | 2026-06-11 |
| Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis Blood sample collection - Non Small Cell Lung Cancer (NSCLC), Melanoma (Skin Cancer) | Not yet recruiting | OncoHost Ltd. | 600 | 2025-11-15 | 2025-11-24 |
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Triple Negative Breast Neoplasms (64) · Breast Neoplasms (18) · Carcinoma, Non-Small-Cell Lung (16) · Squamous Cell Carcinoma of Head and Neck (11) · Colorectal Neoplasms (8) · Carcinoma, Renal Cell (7) · Ovarian Neoplasms (7) · Uterine Cervical Neoplasms (7) · Stomach Neoplasms (5) · Endometrial Neoplasms (4) · Head and Neck Neoplasms (4) · Neoplasms (4) · Urinary Bladder Neoplasms (4) · Mesothelioma (3) · Neoplasm Metastasis (3)
Breast Diseases (64) · Neoplasms by Site (64) · Skin Diseases (64) · Skin and Connective Tissue Diseases (64) · Neoplasms (60) · Breast Neoplasms (46) · Neoplasms by Histologic Type (20) · Lung Diseases (19) · Neoplasms, Glandular and Epithelial (19) · Respiratory Tract Diseases (19) · Respiratory Tract Neoplasms (19) · Thoracic Neoplasms (19) · Bronchial Neoplasms (18) · Carcinoma (18) · Carcinoma, Bronchogenic (18)
pembrolizumab (7) · Paclitaxel (5) · Carboplatin (3) · olaparib (3) · 130-nm albumin-bound paclitaxel (2) · Albumin-Bound Paclitaxel (2) · Cyclophosphamide (2) · Doxorubicin (2) · Drug Therapy (2) · Fluorouracil (2) · Leucovorin (2) · camrelizumab (2) · spartalizumab (2) · ALT-803 (1) · Biological Products (1)
Fudan University (6) · Novartis Pharmaceuticals (3) · A2 Biotherapeutics Inc. (2) · Harbin Medical University (2) · Merck Sharp & Dohme LLC (2) · UNC Lineberger Comprehensive Cancer Center (2) · AbbVie (1) · Adcentrx Therapeutics (1) · Affiliated Hospital of Nantong University (1) · Aiping Shi (1) · Aktis Oncology, Inc. (1) · Antonio Giordano, MD (1) · Arcus Biosciences, Inc. (1) · Boundless Bio, Inc. (1) · Calibr, a division of Scripps Research (1)
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Abirami Sivapiragasam, MD (1) · Aiping Shi, PhD (1) · Andrew Tutt (1) · Antonio C Giordano, MD, PhD (1) · Dana Casey, MD (1) · Eric Ng, MD (1) · Eric W Ng, MD, FAAP (1) · Huiping Li (1) · Joana Mourato Ribiero (1) · Julia Kazakin, MD (1) · Kathryn E Post, PhD, RN, ANP-BC (1)
PMID 33278935, PMID 35362047, PMID 35857659, PMID 36383907, PMID 36457575, PMID 39266535, PMID 41918932, PMID 42362563
2018 (3), 2015 (1), 2016 (1), 2019 (1), 2023 (1), 2025 (1), K08CA286755 (1), R01CA274254 (1)