Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age greater than or equal to 18 years 2.Histologically confirmed triple-negative breast cancer (TNBC), defined as estrogen receptor less than 1 percent, progesterone receptor less than 1 percent, and HER2-negative as per ASCO/CAP criteria 3.Completion of neoadjuvant chemotherapy followed by definitive surgery, either mastectomy or breast-conserving surgery 4.Presence of residual invasive disease in the breast and or axillary lymph nodes on post-surgical pathology 5.Initiation of adjuvant capecitabine therapy, with a minimum of 1 cycle administered Treatment and follow-up managed at ACTREC and Tata Memorial Hospital 6.Availability of comprehensive clinical, treatment, and follow-up data in the institutional electronic medical records
Exclusion criteria
Exclusion criteria: Evidence of metastatic disease at diagnosis or recurrence prior to initiation of capecitabine Prior treatment with capecitabine before surgery (e.g., as part of neoadjuvant regimen) Receipt of non-standard adjuvant therapy not including capecitabine Known hypersensitivity to fluoropyrimidines or clinically significant DPD deficiency Concurrent or prior malignancies (except adequately treated in-situ cervical cancer or non-melanoma skin cancer) Participation in interventional clinical trials during or after capecitabine therapy Incomplete medical records preventing accurate assessment of outcomes or adverse events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Disease-Free Survival Defined as the time from start date of capecitabine therapy to the first documented recurrence (local, regional, or distant) or death from any cause. 2. Overall Survival Defined as the time from start date of capecitabine therapy to death from any cause. Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Treatment Adherence Rate Proportion of patients completing 6 or all 8 cycles of capecitabine as planned 2 Relative Dose Intensity Ratio of delivered dose to the planned dose over the treatment period 3 Adverse Events Incidence and grade of AEs categorized according to CTCAE v5.0Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactAnbarasan Sekar
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
Outcome results
None listed