Clinical trial · Interventional
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
NCT07143097CI-TRIAL-00094192completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple -Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr
- interventionNames
- Drug: capecitabine
- type
- NO_INTERVENTION
- label
- No Intervention: observation after finishing the standard adjuvant treatment
Primary outcomes (1)
- measure
- adverse effents of capictabine
- timeFrame
- assess the adverse effects of the Capecitabine 6 months after starting treatment.
Secondary outcomes (2)
- measure
- distant disease-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.