25 completed, 25 recruiting, 21 active not recruiting, 10 not yet recruiting. 100 Phase 3, 9 Phase 2.
Follow Triple Negative Breast Neoplasms: new trials by email Literature Review of Triple Negative Breast Neoplasms trials Research Report on Triple Negative Breast Neoplasms
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 Study of SYS6043 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Recurrent or Metastatic Triple-Negative Breast Cancer Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available. SYS6043, Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin） - Triple Negative Breast Cancer | Phase 3 | Not yet recruiting | CSPC Megalith Biopharmaceutical Co.,Ltd. | 550 | 2026-11-30 | 2026-10-19 |
| Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery BCS + SRG-514, BCS - TNBC - Triple-Negative Breast Cancer | Phase 3 | Not yet recruiting | SURGE Therapeutics | 400 | 2026-10-01 | 2026-07-23 |
| 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 Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer Trastuzumab Rezetecan for Injection, Adebrelimab Injection, Capecitabine tablets - Triple Negative Breast Cancer | Phase 3 | Recruiting | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | 1000 | 2026-09-02 | 2026-09-09 |
| A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04) BL-B01D1, PD-1 monoclonal antibody, Nab-paclitaxel - Triple-Negative Breast Cancer (TNBC) | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 436 | 2026-09-02 | 2026-09-30 |
| NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer Sacituzumab govitecan, Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA], SoC Chemotherapy - Breast Cancer, Triple-negative Breast Cancer | Phase 3 | Not yet recruiting | Women's Cancer Study Group GmbH | 765 | 2026-08-30 | 2026-08-05 |
| A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer BEBT-209 capsules, Carboplatin Injection, Gemcitabine Hydrochloride for Injection - Locally Advanced Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer | Phase 2 / Phase 3 | Recruiting | BeBetter Med Inc | 446 | 2026-06-04 | 2026-08-18 |
| A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer 9MW2821, Chemotherapy - Locally Advanced or Metastatic Triple-negative Breast Cancer | Phase 3 | Not yet recruiting | Mabwell (Shanghai) Bioscience Co., Ltd. | 356 | 2026-05-01 | 2026-04-30 |
| Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy Standard of care plus pembrolizumab, Standard of care (capecitabine or olaparib) - Triple Negative Breast Cancer (TNBC), Early Setting, Early Stage Triple-Negative Breast Carcinoma | Phase 3 | Not yet recruiting | The Netherlands Cancer Institute | 1000 | 2026-04-01 | 2026-03-20 |
| A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care JSKN016 Injection, Eribulin Mcsilate Injection, Vinorelbine Tartrate Injection - Triple Negative Breast Cancer | Phase 3 | Recruiting | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | 364 | 2026-03-17 | 2026-04-16 |
| 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 |
| A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) Iza-bren, Nab-paclitaxel, Paclitaxel - Breast Neoplasms | Phase 2 / Phase 3 | Recruiting | Bristol-Myers Squibb | 600 | 2025-09-11 | 2026-08-10 |
| A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer ESG401, Investigator's Choice Chemotherapy - Triple-Negative Breast Cancer (TNBC) | Phase 3 | Recruiting | Qilu Pharmaceutical Co., Ltd. | 504 | 2025-09-04 | 2025-09-23 |
| A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer SHR-A1811 for Injection, SHR-1316 Injection, Toripalimab Injection - PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer | Phase 3 | Recruiting | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | 400 | 2025-08-20 | 2025-12-18 |
| Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer Pembrolizumab, Deescalation - Breast Cancers, Triple Negative Breast Cancer (TNBC) | Phase 3 | Recruiting | UNICANCER | 2454 | 2025-07-23 | 2026-07-23 |
| Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer（UPGRADE-TNBC） paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab - Triple-Negative Breast Cancer (TNBC), Neoadjuvant Therapy | Phase 2 / Phase 3 | Enrolling by invitation | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 32 | 2025-07-21 | 2026-08-18 |
| A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication - Breast Neoplasms, Triple Negative Breast Neoplasms | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 2400 | 2025-06-30 | 2026-10-13 |
| A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication - Triple Negative Breast Neoplasms | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 1000 | 2025-03-16 | 2026-10-13 |
| Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer Camrelizumab+Apatinib+Eribulin, Physician's choice chemotherapy - Breast Cancer Stage IV, Triple -Negative Breast Cancer | Phase 3 | Recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 246 | 2025-02-21 | 2026-04-23 |
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