Status:
COMPLETED
Capecitabine as Maintenance Therapy vs Observation in Early-stage Triple-negative Breast Cancer
Lead Sponsor:
Beni-Suef University
Conditions:
Triple -Negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 t...
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 capecitab...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07143097
Start Date
November 1 2021
End Date
May 30 2025
Last Update
August 27 2025
Active Locations (1)
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1
Faculty of Medicine
Banī Suwayf, Egypt