NCT07143097

Capecitabine as Maintenance Therapy vs Observation in Early-stage Triple-negative Breast Cancer

Effect of Capecitabine as Maintenance Therapy Versus Observation on Patients With Early Stage Triple Negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Eligible patients was assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.

Detailed description

Eligible patients will randomly open label assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy. The capecitabine maintenance group will receive oral capecitabine at 650 mg/m2, twice daily continuously for 1 year. Total follow up of the study is 2 years, one year for drug receving with monthy follow up for adverse effect and the other year for every 3 months follow up to asses DFS and OS. Collection of capecitabine dose will receive and adverse events will assessed monthly during capecitabine maintenance in the capecitabine group. In both groups, physical examination, assessment of menopausal status, breast ultrasound, and abdominal ultrasound were performed every 3 months during 2 years of follow up; mammography and chest x-ray were performed yearly. Patients who has not experienced recurrence or death at the time of data analysis will censored as alive and event-free at the date of last follow-up.

Conditions

• Triple -Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	capecitabine 650 mg / m2 twice per day for one year

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-12-30
• Completion: 2025-05-30
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study