NCT06035016

Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer

A Prospective, Multicenter and Registry-based Cohort Study of Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.

Conditions

• HER2-positive Breast Cancer
• Early-stage Breast Cancer

Interventions

Type	Name	Description
DRUG	pyrotinib combined with Capecitabine	Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w
DRUG	treatment of physician's choice	Treatment of physician's choice

Timeline

• Start date: 2023-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

1 site across 1 country: China