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

Not Applicable

Completed

• Conditions: Triple -Negative Breast Cancer
• Interventions: Drug: capecitabine

• Registration Number: NCT07143097
• Lead Sponsor: Beni-Suef University

Brief 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.

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2024-12-30
• Study Completion: 2025-05-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-09
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Eligible trial participants will women who has pathologically confirmed invasive breast ductal carcinoma Hormone receptor negative (<1% positive cells by immunohistochemistry staining) and ERBB2 negative.

Participants had early-stage tumors that were stage T1b-3N0-3cM0, without positive supraclavicular or internal mammary lymph node.

They received standard treatments, including modified radical mastectomy or breast-conserving surgery, neo-/adjuvant chemotherapy, and radiotherapy according to institutional guidelines.

• patients were able to swallow tablets
• performance status 0 - 1

Exclusion Criteria

• Key exclusion criteria will include Inflammatory or bilateral breast cancer. History of invasive breast cancer or other malignancies; receipt of other biologic agents or immunotherapy.

Lactation or pregnancy; or severe coexisting illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr	capecitabine	-

Primary Outcome Measures

Name	Time	Method
adverse effents of capictabine	assess the adverse effects of the Capecitabine 6 months after starting treatment.

Secondary Outcome Measures

Name	Time	Method
distant disease-free survival	up to 24 months from diagnosis	defined as the time from randomization to the first occurrence of the following events: local relapse, distant metastasis or contralateral breast cancer.
overall survival	24 months from diagnosis	the time from randomization to death from any cause

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Banī Suwayf, Egypt