A PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER
- Conditions
- HER2-positive Early Breast Cancer
- Registration Number
- JPRN-jRCT2080224052
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 500
Patients with Stage II-IIIC, locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer
- Primary tumor > 2 cm in diameter, or node-positive
- HER2-positive breast cancer confirmed by a central laboratory
- Hormone receptor status of the primary tumor, centrally confirmed
- Patients who can use method of contraception certainly (Women of childbearing potential must have a negative serum pregnancy test result)
- Patients with a history of invasive breast cancer
- Patients with multicentric breast cancer, unless all tumors are HER2-positive
- Patients with bilateral breast cancer
- Patients with serious cardiac illness or medical conditions
- Patients with known active liver disease or known infection with HIV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method