Phase 3 HER2 Clinical Trials

52 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 52 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 3

BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease

HR+/HER2- Breast Cancer
BeOne Medicines1,056 enrolled13 locationsNCT07492641
Recruiting
Phase 3

Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

Estrogen Receptor-Positive Breast CarcinomaHER2-Negative Breast CarcinomaAnatomic Stage II Breast Cancer AJCC v8+2 more
National Cancer Institute (NCI)1,978 enrolled19 locationsNCT07391774
Recruiting
Phase 3

Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

HER2-Negative Breast CarcinomaAnatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8+1 more
National Cancer Institute (NCI)3,680 enrolled541 locationsNCT06058377
Recruiting
Phase 3

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Advanced Non-small Cell Lung Cancer, HER2 Mutation
Bayer444 enrolled285 locationsNCT06452277
Recruiting
Phase 3

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Breast CancerMetastatic Breast CancerHER2-Negative Breast Carcinoma+2 more
Olema Pharmaceuticals, Inc.1,000 enrolled150 locationsNCT07085767
Recruiting
Phase 3

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Breast NeoplasmsTriple Negative Breast NeoplasmsHR Low-Positive/HER2-Negative Breast Neoplasms
Merck Sharp & Dohme LLC2,400 enrolled296 locationsNCT06966700
Recruiting
Phase 3

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

Breast CancerMetastatic Breast CancerHER2-negative Breast Cancer+3 more
Relay Therapeutics, Inc.540 enrolled192 locationsNCT06982521
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

ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab

Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Early-stage HER2+ Breast Cancer
Alliance for Clinical Trials in Oncology1,524 enrolled656 locationsNCT06876714
Recruiting
Phase 3

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Hoffmann-La Roche1,050 enrolled352 locationsNCT06065748
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

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

HER2-negative Breast CancerER Positive Breast CancerStage III Breast Cancer+1 more
European Organisation for Research and Treatment of Cancer - EORTC220 enrolled109 locationsNCT05512364
Recruiting
Phase 3

Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC

Breast CancerHR+/HER2- Breast Cancer
West German Study Group1,520 enrolled1 locationNCT07242352
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

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

HER2-negative Breast CancerAdvanced Breast CancerER Positive Breast Cancer+1 more
MedSIR240 enrolled99 locationsNCT06382948
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 2Phase 3

A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

HER2 + Breast Cancer
Shanghai Henlius Biotech706 enrolled1 locationNCT07294508
Recruiting
Phase 3

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Breast CancerMetastatic Breast CancerHER2-Negative Breast Carcinoma+2 more
Olema Pharmaceuticals, Inc.510 enrolled233 locationsNCT06016738