Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: ddDCEP: Patients randomized to the treatment arm will receive:
on weeks 1,5,9,13:
Inj. Docetaxel 75 mg/m2 IV in 250 ml NS over 1 hour D1
Inj. Cyclophosphamide 600 mg/m2 IV in 250 ml NS over 30 min D1
and on weeks 3,7,11,15:
Inj Epirubicin 90mg/m2 IV in 100 ml NS over 30 min D1
Inj Cisplatin 60 mg/m2 in 500 ml NS over 2 hours D1
followed by surgery, radiation therapy and adjuvant chemotherapy for those with residual disease.
Control Intervention1: EC-T: Patients randomized to the control arm will receive:
on weeks 1,3,5,7
Inj
followed by surgery, radiation therapy and adjuvant chemotherapy for those with residual disease.
Sponsors
CMC Vellore
Eligibility
Inclusion criteria
Inclusion criteria: Documented histologically confirmed invasive ductal carcinoma of the breast ECOG Performance Status 0-2 Hormone Receptor Status should be documented as negative HER2 documented negative Stage I-IIIC
Exclusion criteria
Exclusion criteria: Pregnant, breastfeeding Multicentric or bilateral disease neuropathy grade 2 or above CCF NYHA class 3 or above LV dysfunction creatinine clearance less than 60 ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients attaining pathological complete response(pCR)Timepoint: at surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of laboratory and clinical adverse events recorded and graded according to CTCAE v5.0.Timepoint: During each chemotherapy cycle;Pathological response of the tumour at the time of resection will be assessed using the following 3 systems: â?¢ Miller Payne system â?¢ RCB (Residual cancer burden) system â?¢ AJCC 8 TNM pathological stagingTimepoint: at surgery;Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.Timepoint: start of chemotherapy, after 4 cycles and at end of chemotherapy;Invasive disease-free survival and Distant disease-free survival Timepoint: 3 years;Overall survivalTimepoint: 3 years;Biomarkers- HRD, TIL, PDL-1 expression. Association with response to chemotherapy and PCRTimepoint: at first biopsy and surgical resection;Dose density, delivery and completion of all planned cycles of chemotherapyTimepoint: at completion of chemotherapy | — |
Countries
India
Contacts
Public ContactJosh Thomas Georgy
CMC Vellore
Outcome results
None listed