Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07470203
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib — DRUG
    240\~320mg given by mouth (orally) once daily every 21days
  • Trastuzuma — DRUG
    6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
  • Pertuzumab — DRUG
    420mg given by IV every 21 days
  • Combination product: Trastuzumab + Pertuzumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
42 participants (estimated)

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ]

Central Contacts

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