11 recruiting, 9 not yet recruiting, 1 active not recruiting, 1 completed. 11 Phase 2, 6 Phase 1, 2 Phase 3, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Not yet recruiting 7, Recruiting 4 |
| Phase 1 | 6 | Recruiting 3, Completed 1, Not yet recruiting 1, Terminated 1 |
| Phase 3 | 2 | Not yet recruiting 1, Recruiting 1 |
| Phase 4 | 2 | Recruiting 2 |
Follow HER2 + Breast Cancer: new trials by email Literature Review of HER2 + Breast Cancer trials Research Report on HER2 + Breast Cancer
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 HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients HLX22, Trastuzumab, Capecitabine - HER2 + Breast Cancer | Phase 2 | Not yet recruiting | Shanghai Henlius Biotech | 90 | 2026-10-31 | 2026-09-17 |
| Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer Trastuzumab Rezetecan, Pyrotinib, trastuzumab - HER2 + Breast Cancer, Advanced Breast Cancer | Phase 2 | Not yet recruiting | Fujian Cancer Hospital | 50 | 2026-09-30 | 2026-08-14 |
| Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study Paclitaxel oral solution plus Trastuzumab and Pertuzumab - HER2 + Breast Cancer | Phase 1 / Phase 2 | Recruiting | Liu Shu | 30 | 2026-07-29 | 2026-08-04 |
| Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer Pyrotinib, Trastuzumab Rezetecan - HER2 + Breast Cancer, Advanced Breast Cancer | Phase 4 | Recruiting | Peking University People's Hospital | 500 | 2026-07-06 | 2026-07-13 |
| A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer HLX319, EU-Phesgo® - HER2 + Breast Cancer | Phase 1 | Not yet recruiting | Shanghai Henlius Biotech | 258 | 2026-07-03 | 2026-05-22 |
| 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 | |
| Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients SHR-A1811 - HER2positive, Advanced Breast Cancer | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 60 | 2026-06-10 | 2026-06-11 |
| Olaparib+Trastuzumab+Pertuzumab Neoadjuvant for Elderly HER2+ Breast Cancer olaparib combined with trastuzumab and pertuzumab - Elderly Females, HER2 + Breast Cancer | Phase 4 | Recruiting | Wen-Ming Cao | 45 | 2026-05-25 | 2026-07-10 |
| Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib Abemaciclib - Breast Cancer, HER2 + Breast Cancer | Phase 2 | Not yet recruiting | Mario Negri Institute for Pharmacological Research | 150 | 2026-04-30 | 2026-03-05 |
| A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer HLX87 + HLX22, HLX87 + Pertuzumab, T-Dxd + Pertuzumab - HER2 + Breast Cancer | Phase 2 / Phase 3 | Recruiting | Shanghai Henlius Biotech | 706 | 2026-02-27 | 2026-03-20 |
| Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer Trastuzumab Deruxtecan, Pertuzumab, Taxane Chemotherapy - HER2 + Breast Cancer | Phase 2 | Recruiting | Shanghai Jiao Tong University School of Medicine | 50 | 2026-02-02 | 2026-02-06 |
| A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer HLX87+HX22, HLX87 + Pertuzumab, TCbHP - HER2 + Breast Cancer | Phase 2 / Phase 3 | Not yet recruiting | Shanghai Henlius Biotech | 817 | 2026-01-27 | 2025-12-19 |
| Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies There are no interventions in this observational study. - Breast Cancer, TNBC - Triple-Negative Breast Cancer | Recruiting | Tempus AI | 900 | 2025-10-27 | 2026-09-03 | |
| A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer [177Lu]Lu-ABY-271 - Metastatic Breast Cancer, HER2 + Breast Cancer | Phase 1 | Recruiting | Affibody | 21 | 2025-10-06 | 2025-10-01 |
| SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response SHR-A1811 - Early Breast Cancer, HER2 + Breast Cancer | Phase 2 | Not yet recruiting | Chuan Wang | 30 | 2025-10-01 | 2025-08-26 |
| Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer. TQB2102, Docetaxel + Carboplatin + Trastuzumab +Pertuzumab - Breast Cancer, HER2 + Breast Cancer | Phase 2 | Not yet recruiting | Henan Cancer Hospital | 280 | 2025-09-01 | 2025-08-22 |
| A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer Two Component Product CLBR001 + ABBV-461 - Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC) | Phase 1 | Terminated | Calibr, a division of Scripps Research | 10 | 2025-04-17 | 2026-05-28 |
| HER2-positive Breast Cancer Registry HER2 + Breast Cancer | Recruiting | Priyanka Sharma | 1000 | 2024-09-27 | 2026-07-17 | |
| Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Patients Who Achieved Durable Response to Anti-HER2 Treatment Trastuzumab (Herceptin), SIgnatera - Breast Cancer, Metastatic, HER2 + Breast Cancer | Active not recruiting | Nagoya City University | 50 | 2024-04-01 | 2026-05-13 | |
| A Phase 1/1b Study of IAM1363 in HER2 Cancers IAM1363 - HER2 Mutation-Related Tumors, HER2 | Phase 1 | Recruiting | Iambic Therapeutics, Inc | 383 | 2024-03-25 | 2026-09-09 |
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Breast Neoplasms (23) · Triple Negative Breast Neoplasms (3) · Neoplasm, Residual (2) · Stomach Neoplasms (2) · Brain Neoplasms (1) · Carcinoma, Non-Small-Cell Lung (1) · Esophageal Squamous Cell Carcinoma (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Squamous Cell Carcinoma of Head and Neck (1)
Breast Diseases (23) · Neoplasms by Site (23) · Skin Diseases (23) · Skin and Connective Tissue Diseases (23) · Neoplasms (22) · Digestive System Diseases (2) · Digestive System Neoplasms (2) · Gastrointestinal Diseases (2) · Gastrointestinal Neoplasms (2) · Neoplastic Processes (2) · Pathologic Processes (2) · Pathological Conditions, Signs and Symptoms (2) · Stomach Diseases (2) · Brain Diseases (1) · Bronchial Neoplasms (1)
Trastuzumab (6) · pertuzumab (5) · pyrotinib (4) · trastuzumab deruxtecan (3) · Capecitabine (2) · Docetaxel (2) · Paclitaxel (2) · Ado-Trastuzumab Emtansine (1) · Bevacizumab (1) · Biosimilar Pharmaceuticals (1) · Carboplatin (1) · RC48 antibody (1) · Vinorelbine (1) · abemaciclib (1) · disitamab vedotin (1)
Shanghai Henlius Biotech (4) · Affibody (1) · Calibr, a division of Scripps Research (1) · Chuan Wang (1) · Federico II University (1) · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (1) · Fujian Cancer Hospital (1) · Henan Cancer Hospital (1) · Iambic Therapeutics, Inc (1) · Liu Shu (1) · Mario Negri Institute for Pharmacological Research (1) · Nagoya City University (1) · Novartis Pharmaceuticals (1) · Peking University People's Hospital (1) · Priyanka Sharma (1)
China (9) · United States (6) · Italy (3) · South Korea (2) · Spain (2) · Canada (1) · France (1) · Ireland (1) · Japan (1) · Netherlands (1) · Sweden (1) · Taiwan (1) · United Kingdom (1)
Fei Ma, Dr (1) · Michelle Ting-Lin, MD (1) · Zhiming Shao, Dr (1)