drugset / Trial / NCT05292742

Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer

NCT05292742

Phase 2 Recruiting 206 enrolled Fujian Medical University Union Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy

Timeline

Start
2021-07-02
Primary completion
2026-10-01
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Comparator Pertuzumab Monoclonal antibody 420 mg
Subject Pyrotinib Small molecule 400 mg Oral
Comparator Trastuzumab Monoclonal antibody 6 mg/kg

Indications