Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: paclitaxel and carboplatin during the waiting period of starting definitive therapy: Injection Paclitaxel 80 mg/m2 in 1 unit NS in Glass bottle IV infusion over 1 hour using DEHP free s
Sponsors
ICMR Adhoc extramural grant
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed triple-negative breast cancer. Age 18 -65 years. ECOG PS 0/1. Early and locally advanced breast cancer (T2/T3/T4b with or without node positive). Planned for neo-adjuvant chemotherapy with anthracycline and taxanes. Bone marrow function- Hb > 9g%, absolute neutrophil count > 1500/ micL, platelet > 1.5 lakhs/ mic L. Renal function- Serum creatinine Liver function- Serum bilirubin > 1.5 mg%. Normal cardiac function.Â
Exclusion criteria
Exclusion criteria: The patient is not willing to the second biopsy Pregnant women Breast feeding mother Prior history of any other malignancy Bilateral breast cancer Patient having active local site infection Previous allergy to chemotherapy drugs paclitaxel and carboplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The expected outcome from this project is to identify pathological, imaging, and molecular biomarker which would predict pCR in TNBC patients using the window period before NACT. We would develop a predictive score that will enable us to identify patients who will achieve pCR. This score needs to be validated in a larger population. Once validated we will prospectively use this score in a clinical trial setting to decide on chemotherapy intensity in TNBC patients planned for NACT. Timepoint: post neoadjuvant chemotherapy, at the end of the surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| disease free survivalTimepoint: post surgery followup of patients | — |
Countries
India
Contacts
Public ContactDr Biswajit Dubashi
JIPMER, Puducherry
Outcome results
None listed