NCT05188495

Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab

Phase II Study of Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Currently, data of the efficacy of trastuzumab plus pertuzumab and chemotherapy is limited in the HER2 positive metastatic breast cancer patients previously treated with trastuzumab during (neo)adjuvant and metastatic setting, and results are not consistent.The main purpose of this study is to evaluate the 6-month progression free survival(PFS) of trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy as first to third line therapy in Chinese patients with HER2 positive metastatic breast cancer who received trastuzumab previously.Primary Endpoint is 6-month Progression-free survival (PFS);Secondary Endpoint(s) include Progression-free survival (PFS) Overall Survival (OS);Objective Response Rate(ORR);

Conditions

• HER2-positive Metastatic Breast Cancer
• Previously Treated With Trastuzumab
• Trastuzumab Combined With Pertuzumab and Chemotherapy

Interventions

Type	Name	Description
DRUG	trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy	trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy； TPC:treatment of physician's choice,include taxanes，Gemcitabine, capecitabine, vinorelbine

Timeline

• Start date: 2021-05-10
• Primary completion: 2023-12-10
• Completion: 2023-12-10
• First posted: 2022-01-12
• Last updated: 2022-01-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study