7 recruiting, 5 not yet recruiting, 2 active not recruiting, 1 enrolling by invitation. 10 Phase 2, 5 Phase 1, 2 Not applicable, 1 Phase 3.
Follow TNBC: new trials by email Literature Review of TNBC trials Research Report on 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 |
|---|---|---|---|---|---|---|
| Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer Live biotherapeutic product: MO-03 1 capsule PO BID - TNBC - Triple-Negative Breast Cancer, TNBC | Phase 2 | Not yet recruiting | Yuan Yuan | 50 | 2026-09-01 | 2026-08-05 |
| A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer. Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapy - TNBC, Adjuvant Therapy | Not applicable | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 59 | 2026-06-05 | 2026-06-03 |
| A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer treatment group - TNBC | Not applicable | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 43 | 2026-03-25 | 2026-03-24 |
| A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation Inavolisib in Combination With Eribulin - TNBC - Triple-Negative Breast Cancer, TNBC | Phase 2 | Not yet recruiting | Hu Hai | 26 | 2026-03-15 | 2026-03-02 |
| Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases Sacituzumab Tirumotecan (Sac-TMT), bevacizumab - TNBC, Brain Metastasis | Phase 2 | Recruiting | Fudan University | 24 | 2026-01-01 | 2026-06-03 |
| A Study of HB0025 Plus Nab-paclitaxel as First Line Therapy for TNBC HB0025 20 mg/kg plus nab-paclitaxel, HB0025 10 mg/kg plus nab-paclitaxel - TNBC | Phase 2 | Enrolling by invitation | Huabo Biopharm Co., Ltd. | 60 | 2025-08-14 | 2026-01-29 |
| Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer Ivonescimab, Carboplatin, Docetaxel - TNBC, TNBC - Triple-Negative Breast Cancer | Phase 2 | Recruiting | Cedars-Sinai Medical Center | 34 | 2025-07-25 | 2026-08-04 |
| Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients Utidelone plus capecitabine, Capecitabine - Breast Cancer, TNBC | Phase 3 | Not yet recruiting | Fudan University | 440 | 2025-06-16 | 2025-06-13 |
| A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression A2B395, xT CDx with HLA-LOH assay - Solid Tumor, Adult, Colorectal Cancer | Phase 1 / Phase 2 | Recruiting | A2 Biotherapeutics Inc. | 240 | 2025-05-22 | 2025-09-09 |
| HS-10502 Combination Treatment in Patients With Advanced Solid Tumors HS-10502 + NHA, HS-10502 + HS-20093, HS-10502+ Apatinib - Recurrent Ovarian Cancer, HER2-negative | Phase 1 | Recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 157 | 2025-05-07 | 2025-06-24 |
| Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration Sacituzumab Govitecan (SG)+Toripalimab - TNBC | Recruiting | Peking University Cancer Hospital & Institute | 51 | 2025-05-01 | 2025-05-28 | |
| A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer IMM2510, Chemotherapy (pemetrexed + cisplatin/carboplatin), Chemotherapy (paclitaxel + cisplatin/carboplatin) - NSCLC, TNBC | Phase 2 | Not yet recruiting | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | 148 | 2024-12-01 | 2024-12-24 |
| SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases SHR-A1921 + Bevacizumab - TNBC, Brain Metastasis | Phase 2 | Unknown | Fudan University | 24 | 2024-02-01 | 2024-01-18 |
| A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors Enzelkitug, Atezolizumab, Pembrolizumab - Locally Advanced or Metastatic Solid Tumors, NSCLC | Phase 1 | Active not recruiting | Genentech, Inc. | 165 | 2022-10-20 | 2026-11-03 |
| A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC PM8002, nab-paclitaxel - TNBC | Phase 1 / Phase 2 | Active not recruiting | Biotheus Inc. | 42 | 2022-07-01 | 2025-03-11 |
| The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) rezatapopt, pembrolizumab - Advanced Solid Tumor, Advanced Malignant Neoplasm | Phase 1 / Phase 2 | Recruiting | PMV Pharmaceuticals, Inc | 300 | 2020-10-29 | 2026-10-02 |
| An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC) leronlimab (PRO 140) - TNBC, TNBC - Triple-Negative Breast Cancer | Temporarily not available | CytoDyn, Inc. | 2026-10-26 |
Triple Negative Breast Neoplasms (7) · Breast Neoplasms (3) · Colorectal Neoplasms (3) · Brain Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (2) · Carcinoma, Renal Cell (2) · Lung Neoplasms (2) · Ovarian Neoplasms (2) · Prostatic Neoplasms (2) · Squamous Cell Carcinoma of Head and Neck (2) · Stomach Neoplasms (2) · Carcinoma, Transitional Cell (1) · Colonic Neoplasms (1) · Endometrial Neoplasms (1) · Esophageal Neoplasms (1)
Neoplasms by Site (12) · Neoplasms (11) · Skin Diseases (10) · Skin and Connective Tissue Diseases (10) · Breast Diseases (9) · Breast Neoplasms (6) · Digestive System Diseases (4) · Digestive System Neoplasms (4) · Female Urogenital Diseases (4) · Female Urogenital Diseases and Pregnancy Complications (4) · Gastrointestinal Diseases (4) · Gastrointestinal Neoplasms (4) · Male Urogenital Diseases (4) · Urogenital Diseases (4) · Urogenital Neoplasms (4)
130-nm albumin-bound paclitaxel (3) · Bevacizumab (3) · Carboplatin (2) · Docetaxel (2) · pembrolizumab (2) · Capecitabine (1) · Cisplatin (1) · Drug Therapy (1) · Irinotecan (1) · Paclitaxel (1) · Pemetrexed (1) · Platinum (1) · atezolizumab (1) · eribulin (1) · inavolisib (1)
Fudan University (3) · A2 Biotherapeutics Inc. (1) · Biotheus Inc. (1) · Cedars-Sinai Medical Center (1) · CytoDyn, Inc. (1) · Genentech, Inc. (1) · Hu Hai (1) · Huabo Biopharm Co., Ltd. (1) · ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (1) · Jiangsu Hansoh Pharmaceutical Co., Ltd. (1) · PMV Pharmaceuticals, Inc (1) · Peking University Cancer Hospital & Institute (1) · The First Affiliated Hospital with Nanjing Medical University (1) · Tianjin Medical University Cancer Institute and Hospital (1) · Yuan Yuan (1)
China (7) · United States (6) · Australia (2) · South Korea (2) · Spain (2) · Belgium (1) · Canada (1) · France (1) · Germany (1) · Greece (1) · Italy (1) · Netherlands (1) · Singapore (1) · Taiwan (1) · United Kingdom (1)
Yuan Yuan, MD (2) · Jin Sun Lee-Bitar, MD (1) · John Welch, MD, PhD (1) · Marc Fellous, MD (1) · Qiying Lu, MD (1) · Wu Jiong (1)
PMID 40543428, PMID 40932470, PMID 41740031
2023 (1)