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

A Randomized, Open-label, Multicenter Study Comparing 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Breast Cancer
• Adjuvant Therapy

Interventions

Type	Name	Description
DRUG	Pyrotinib+Trastuzumab+Capecitabine	Patients in the experimental arm will receive trastuzumab + pyrotinib + capecitabine
DRUG	Trastuzumab+Pertuzumab/Trastuzumab	Trastuzumab: Initial loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks. One year of trastuzumab treatment (including: neoadjuvant phase and adjuvant phase) Pertuzumab: 840 mg loading dose followed by 420 mg fixed dose

Timeline

• Start date: 2021-07-02
• Primary completion: 2026-10-01
• Completion: 2027-12-31
• First posted: 2022-03-23
• Last updated: 2022-03-23

Locations

1 site across 1 country: China