Phase 3 HER2-positive Clinical Trials

25 recruitingPhase 3

What is a Phase 3 trial?

Phase 3 trials compare the new treatment against the current standard of care in large groups, often hundreds to thousands of participants. Successful Phase 3 results are typically required for regulatory approval.

Showing 120 of 25 trials

Recruiting
Phase 3

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

Gastroesophageal Junction AdenocarcinomaHER2-positive Gastric Cancer
AstraZeneca840 enrolled293 locationsNCT06764875
Recruiting
Phase 2Phase 3

RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive

HER2-positive Breast Cancer
Hoffmann-La Roche650 enrolled55 locationsNCT07413939
Recruiting
Phase 3

A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

HER2-positive Breast Cancer
Sichuan Baili Pharmaceutical Co., Ltd.596 enrolled2 locationsNCT07518173
Recruiting
Phase 3

TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer

HER2-positive Advanced Breast Cancer
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.416 enrolled75 locationsNCT07047365
Recruiting
Phase 3

A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer

Resectable HER2-positive Breast Cancer
Shanghai JMT-Bio Inc.1,800 enrolled1 locationNCT07441460
Recruiting
Phase 3

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

HER2-positive Breast Cancer
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.544 enrolled78 locationsNCT07043725
Recruiting
Phase 3

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Gastric CancerGastroesophageal-junction CancerHER2-positive Gastric Cancer+1 more
Shanghai Henlius Biotech550 enrolled208 locationsNCT06532006
Recruiting
Phase 3

IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer

HER2-positive Breast Cancer
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.540 enrolled1 locationNCT07377643
Recruiting
Phase 3

A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

Metastatic HER2-positive Breast Cancer
Jazz Pharmaceuticals550 enrolled166 locationsNCT06435429
Recruiting
Phase 3

A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer

Early-stage or Locally Advanced HER2-positive Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.740 enrolled2 locationsNCT07196774
Recruiting
Phase 3

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

HER2-positive Breast Cancer
Sichuan Baili Pharmaceutical Co., Ltd.1,450 enrolled2 locationsNCT06830889
Recruiting
Phase 2Phase 3

A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

HER2-positive Breast Cancer
Sichuan Baili Pharmaceutical Co., Ltd.120 enrolled30 locationsNCT06891833
Recruiting
Phase 3

Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab

HER2-positive Breast CancerEarly Stage Breast CancerAdjuvant Treatment After Trastuzumab+2 more
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University300 enrolled1 locationNCT05760612
Recruiting
Phase 3

Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer

HER2-positive Breast Cancer
NRG Oncology1,300 enrolled416 locationsNCT05705401
Recruiting
Phase 3

A Randomized, Open-label, Multi-center Phase III Study Comparing the Efficacy of Oral Chemotherapy Combined With Trastuzumab Versus Paclitaxel Combined With Trastuzumab in the Adjuvant Treatment of HER2-positive, Lymph Node-negative Early Breast Cancer Patients(ORCHID-PLUS)

HER2-positive Breast Cancer
Fudan University2,306 enrolled1 locationNCT06992882
Recruiting
Phase 3

Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients

Biliary Tract CancerAdvanced CancerMetastatic Biliary Tract Carcinoma+2 more
Tata Memorial Centre220 enrolled6 locationsNCT07062263
Recruiting
Phase 3

Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Shanghai JMT-Bio Inc.880 enrolled1 locationNCT05838066
Recruiting
Phase 3

A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy

HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Jiangsu HengRui Medicine Co., Ltd.1,600 enrolled2 locationsNCT06126640
Recruiting
Phase 2Phase 3

The Impact of Intelligent Patient Management Model on Medication Adherence of Pyrotinib Compared to Traditional Patient Management Model: a Prospective, Multicenter, Randomized Controlled Clinical Study

HER2-positive Breast CancerPyrotinib Treatment
Cancer Institute and Hospital, Chinese Academy of Medical Sciences964 enrolled1 locationNCT06958627
Recruiting
Phase 3

A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

Early or Locally Advanced HER2-positive Breast Cancer
Shanghai JMT-Bio Inc.520 enrolled1 locationNCT06747338