Capecitabine as Maintenance Therapy vs Observation in Early-stage Triple-negative Breast Cancer
NCT ID: NCT07143097
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2021-11-01
2025-05-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr
capecitabine
capecitabine 650 mg / m2 twice per day for one year
No Intervention: observation after finishing the standard adjuvant treatment
No interventions assigned to this group
Interventions
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capecitabine
capecitabine 650 mg / m2 twice per day for one year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Beni-Suef University
OTHER
Responsible Party
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Sarah Hamdy Ali Sayed
assistant lecturer of clinical oncology
Locations
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Faculty of Medicine
Banī Suwayf, , Egypt
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FMBSUREC/10102021/Sayed
Identifier Type: -
Identifier Source: org_study_id
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