Disease landscape

HER2-Positive Breast Cancer clinical trials

Get alerts when HER2-Positive Breast Cancer trials change

175 active trials 98 recruiting 33 Phase 3 107 sponsors 25 changes in 30 days

Data updated daily from ClinicalTrials.gov, last refresh 2026-09-05

What changed in the last 30 days

2026-09-04
Primary completion pushed: 2026-06-22 → 2026-12-22
Completion pushed: 2027-07-21 → 2027-12-21
NCT04886531 Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive… · Ruth O'Regan · Phase 2
2026-09-03
Primary completion pushed: 2028-12-30 → 2030-12-30
Primary endpoint(s) modified
Phase changed: Phase 1 → Phase 1/2
Enrollment increased: 124 → 280 participants
Interventions modified
Trial sites expanded: 7 → 10 locations
Completion pushed: 2029-12-30 → 2031-12-30
Trial arms changed: 2 → 3
NCT05868226 PRE-ISPY Phase I/II Oncology Platform Program · QuantumLeap Healthcare Collaborative · Phase 1/2
2026-08-29
Primary completion pushed: 2026-04 → 2027-04
Trial sites reduced: 14 → 8 locations
Completion pushed: 2032-04 → 2032-11
NCT06068985 Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With… · Latin American Cooperative Oncology Group · Phase 2
2026-08-20
Primary completion pushed: 2026-11-01 → 2028-11-01
Completion pushed: 2028-05-01 → 2029-05-01
NCT04893109 ATEMPT 2.0: Adjuvant T-DM1 vs TH · Dana-Farber Cancer Institute · Phase 2
2026-08-28
Primary endpoint(s) modified
Interventions modified
NCT06414733 HER-2 B Cell Peptide Vaccine · Pravin T.P Kaumaya · Phase 1
2026-08-09
Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University → Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT07616427 Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted… · Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2
2026-08-09
Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University → Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT07616440 Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug… · Second Affiliated Hospital, School of Medicine, Zhejiang University
2026-08-15
Recruitment opened
NCT07543536 Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer · Sun Yat-sen University · Phase 3
2026-08-27
Enrollment increased: 120 → 985 participants
Trial arms changed: 1 → 2
NCT06891833 A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin +… · Sichuan Baili Pharmaceutical Co., Ltd. · Phase 2/3
2026-08-22
Enrollment closed, study ongoing
NCT04360941 PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer · Royal Marsden NHS Foundation Trust · Phase 1
2026-09-04
Trial sites expanded: 152 → 186 locations
NCT07413939 RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People… · Hoffmann-La Roche · Phase 2/3
2026-09-03
Trial sites expanded: 684 → 690 locations
NCT06876714 ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+… · Alliance for Clinical Trials in Oncology · Phase 3

New sponsor entrants, last 90 days sponsors with their first trial in this area

First postedTrialSponsorPhase
2026-08-05 NCT07748260 De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast Guangdong Provincial People's Hospital new Phase 3
2026-07-24 NCT07726342 SMP-656 for HER2-Positive Advanced Breast Cancer Chengdu SciMount Pharmatech Co., Ltd. new Phase 2
2026-07-15 NCT07706179 Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast… University of Wisconsin, Madison new Phase 2
2026-06-29 NCT07673029 A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or… GeneQuantum Healthcare (Suzhou) Co., Ltd. new Phase 3
2026-06-15 NCT07647263 Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast… The First Affiliated Hospital of Soochow University new Phase 2

Active trials by phase

Early Phase 1
1
Phase 1
10
Phase 1/2
12
Phase 2
66
Phase 2/3
5
Phase 3
28
Phase 4
4
Not charted: 49 active trials with no phase listed on ClinicalTrials.gov (typically behavioural, device, procedure and observational studies).

Active trials top 25 of 175

NCT IDTitleSponsorStatusUpdated
Phase 4
NCT06217185 The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment… Hebei Medical University Fourth Hospital Recruiting 2024-02-28
NCT07768358 Tucatinib Continuation Study Pfizer Not Yet Recruiting 2026-08-28
NCT07589699 Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP The First Affiliated Hospital with Nanjing Medical University Not Yet Recruiting 2026-05-15
NCT06868017 Randomized Controlled Clinical Study of Efficacy and Safety of Initumab Combined with… The First Hospital of Jilin University Not Yet Recruiting 2025-03-10
Phase 3
NCT06876714 ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+… Alliance for Clinical Trials in Oncology Recruiting 2026-09-02
NCT07543536 Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer Sun Yat-sen University Recruiting 2026-08-14
NCT07673029 A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or… GeneQuantum Healthcare (Suzhou) Co., Ltd. Recruiting 2026-06-29
NCT07518173 A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and… Sichuan Baili Pharmaceutical Co., Ltd. Recruiting 2026-06-04
NCT07441460 A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable… Shanghai JMT-Bio Inc. Recruiting 2026-04-08
NCT07043725 A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal… Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Recruiting 2026-03-27
NCT07377643 IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in… Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. Recruiting 2026-02-25
NCT06435429 A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in… Jazz Pharmaceuticals Recruiting 2026-02-10
NCT06830889 A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer… Sichuan Baili Pharmaceutical Co., Ltd. Recruiting 2026-01-22
NCT05760612 Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth… Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting 2025-09-25
NCT06992882 A Randomized, Open-label, Multi-center Phase III Study Comparing the Efficacy of Oral… Fudan University Recruiting 2025-07-18
NCT01785420 Pre Operative Trastuzumab in Operable Breast Cancer Dr Rajendra A. Badwe Recruiting 2025-04-09
NCT06846437 JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer Shanghai JMT-Bio Inc. Recruiting 2025-03-24
NCT06313086 DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast… CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Recruiting 2024-05-10
NCT07748260 De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast Guangdong Provincial People's Hospital Not Yet Recruiting 2026-08-05
NCT07196774 A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in… Jiangsu HengRui Medicine Co., Ltd. Active, Not Recruiting 2026-07-30
NCT03975647 A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1)… Seagen, a wholly owned subsidiary of Pfizer Active, Not Recruiting 2026-07-23
NCT06316531 A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or… Sichuan Baili Pharmaceutical Co., Ltd. Active, Not Recruiting 2026-07-23
NCT05132582 A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+… Seagen, a wholly owned subsidiary of Pfizer Active, Not Recruiting 2026-07-22
NCT06747338 A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant… Shanghai JMT-Bio Inc. Active, Not Recruiting 2026-07-07
NCT04208178 Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance… Novartis Pharmaceuticals Active, Not Recruiting 2026-06-11
See all 175 active HER2-Positive Breast Cancer trials with filters →

Top sponsors by active trials in this area

Fudan University (9) · Shu Wang (7) · Dana-Farber Cancer Institute (5) · H. Lee Moffitt Cancer Center and Research Institute (5) · Sichuan Baili Pharmaceutical Co., Ltd. (5) · Hebei Medical University Fourth Hospital (4) · Memorial Sloan Kettering Cancer Center (4) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (3) · Hoffmann-La Roche (3) · Shanghai JMT-Bio Inc. (3)

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