NCT07143097CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 9 Aug 2025
- Start date
- 1 Nov 2021
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Beni-Suef University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07143097
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- From 1 Nov 2021 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Coordinator of this site? Confirm its status | Banī Suwayf | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.