Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer
NCT07470203 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 42
Last updated 2026-03-13
Summary
This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.
Conditions
Interventions
- DRUG
-
Pyrotinib
240\~320mg given by mouth (orally) once daily every 21days
- DRUG
-
Trastuzuma
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
- DRUG
-
420mg given by IV every 21 days
- DRUG
-
Combination product: Trastuzumab + Pertuzumab
600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2029-03-31
- Completion
- 2029-09-30
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