drugset
drugset / Trial / NCT06483386

Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer

NCT06483386 ↗

Phase 2 Not yet recruiting 109 enrolled Tianjin Medical University Cancer Institute and Hospital
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2024-07-15
Primary completion
2026-06-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Pyrotinib Small molecule 400 mg Oral
Subject Trastuzumab Monoclonal antibody 600 mg Subcutaneous

Indications

female breast carcinoma