Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer
NCT06483386 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109
Last updated 2024-07-03
Summary
Objective: To explore the efficacy and safety of Pyrotinib, trastuzumab subcutaneous preparation and capecitabine neoadjuvant therapy for early HER2+breast cancer.
Administration method: 6 cycles throughout the entire process:
Pyrotinib Maleate Tablets: Continuously administered from the first day of the first course of treatment, 400 Mg/day, orally administered within 30 minutes after breakfast Trastuzumab: Subcutaneous injection, 600mg, d1, q3w Capecitabine: oral, 1000 mg/m2, bid d1-14, q3w Premenopausal goserelin 3.6mg once every 28 days
Conditions
Interventions
- DRUG
-
Pyrotinib and Subcutaneous preparation of trastuzumab combined with capecitabine
Pyrotinib and Subcutaneous preparation of trastuzumab combined with capecitabine
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-15
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-30
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