Efficacy and Safety of Supplement Adjuvant Capecitabine in Postoperative Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative High-risk Breast Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2029-12-01

Summary

According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has replaced lung cancer as the most of new cancer with 2.26 million new cases. Among Chinese breast cancer patients, about 60% are hormone receptor (HR) positive and about 80% have early-stage breast cancer. For HR-positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer patients, the first peak of recurrence is about 2-3 years after surgery, especially for patients with high-risk clinical and/or pathological features. Therefore, adjuvant therapy for the first 2 years after surgery is essential to reduce recurrence. Capecitabine is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate that can be converted to fluorouracil (5-Fu) in vivo. Studies have shown that patients with HR-positive HER2-negative breast cancer with high-risk factors may benefit from postoperative adjuvant capecitabine therapy as well as patients with triple-negative breast cancer. This trial is an open, single-arm clinical trial designed to investigate the effect of additional adjuvant capecitabine therapy on recurrence and survival in HR-positive HER2-negative breast cancer patients with high-risk factors.

• Phase: Phase 3

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Capecitabine