Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis: Confirmed early-stage triple-negative breast cancer (TNBC). Treatment: Eligible for neoadjuvant chemotherapy (NACT) for TNBC. Age: Females 18 and above Consent: Able and willing to provide informed consent. Organ Function: Adequate liver, renal, and blood counts. Follow-up Compliance: Willingness for regular follow-up and blood sampling. Baseline Sample: Available baseline blood sample pre-NACT.
Exclusion criteria
Exclusion criteria: Metastatic Disease: Presence of metastatic breast cancer. Previous Malignancies: Other malignancies within a specified recent period. Concurrent Trials: Participation in other clinical trials with investigational drugs. Major Health Conditions: Uncontrolled diabetes, severe cardiovascular diseases, or infections. Pregnancy/Breastfeeding: Currently pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i. Pathological Complete Response (pCR) ii. Overall Survival (OS) iii. Progression-Free Survival (PFS): iv. Disease-Free Survival (DFS):Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Recurrence Rate ii. CTC and ctDNA Levels Correlation with Survival Outcomes iii. Time to Recurrence iv. Biomarker DynamicsTimepoint: 3 years | — |
Countries
India
Contacts
Max Super Speciality Hospital Saket (East Block) (A unit of Devki Devi Foundation)