At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically proven TNBC with HER2 negativity and <10% ER/PgR staining
- ✓Prior neoadjuvant chemotherapy with minimum 6 cycles including pembrolizumab, anthracyclines and/or taxanes
- ✓Complete resection of breast tumor(s) and invaded lymph nodes
- ✕Radiological or clinical evidence of metastatic disease
- ✕Prior capecitabine or other ICI besides pembrolizumab in NAC regimen
- ✕Known additional malignancy (except skin cancers or in situ cervical cancer or previously treated with ≥2 years disease-free)
- ✕Contraindication to pembrolizumab including hypersensitivity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study to Evaluate CAPecitabine Plus Pembrolizumab as Post-operative Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapy
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab injection, Capecitabine tablets, and 1 other intervention for Triple Negative Breast Neoplasms. Currently recruiting, targeting 220 participants across 20 sites.
Signals
Detailed Summary
The goal of this clinical trial is to evaluate the efficacity and safety of pembrolizumab and capecitabine on the invasive disease-free survival, in participants who have triple negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy associated with pembrolizumab.
Study Details
Timeline
Interventions
On Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion
1250 mg/m² BID, on days 1-14 of each 21-day cycle; 8 cycles Dose reduction at 825 mg/m² BID during radiotherapy if indicated
Local radiotherapy will be performed as per standard practice if indicated.