At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 876 enrolled
Drug / intervention
Capecitabinedrug
Likely dose
Capecitabine (dose not specified in trial document)AI-extracted
Key inclusion· 7
- ✓Histologically confirmed operable invasive adenocarcinoma of the breast, HER2-negative, T1-T3 stage
- ✓Node-negative disease with tumor size >2 cm, OR node-positive disease with ≥1 of 6 nodes involved (pN1a, pN2a, or pN3a)
- ✓Negative hormone receptor status (ER/PR) confirmed before end of adjuvant chemotherapy
- ✓Completed ≥6 courses of adjuvant chemotherapy with anthracyclines and/or taxanes, within 8 weeks of randomization (4 weeks if also received radiotherapy)
Key exclusion· 12
- ✕Males
- ✕Bilateral invasive breast cancer
- ✕T4 or M1 tumors
- ✕Node-positive disease with internal mammary node involvement (pN1b, pN1c, pN2b, pN3b, pN3c)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients
In Brief
A Phase 3 clinical trial evaluating Capecitabine for Breast Cancer. Completed, enrolled 876 participants across 48 sites.
Detailed Summary
This is a prospective, open-label, randomized phase III study assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer.
Study Details
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2005
Enrollment StartJan 2006
Primary CompletionFeb 2017
TodayJul 2026
First PostedAug 15, 2005
Enrollment StartJan 1, 2006
Primary CompletionFeb 17, 2017
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 20.9 years ago
Interventions
Capecitabinedrug