Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: ARM B: patient will receive doxorubicin (60 mg/m²) and cyclophosphamide (600 mg/m²) every 2 weeks for four cycles followed by paclitaxel (80 mg/m² intravenously weekly for 12 doses)
Sponsors
Dr B Borooah Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: -Age more than 18 years -ECOG performance score less than or equals to 1 -Staging done prior to randomization -Creatinine levels indicating renal clearance more than or equals to 50 ml/min -Bilirubin less than 3 x UNL -Biopsy/FNAC proven carcinoma Breast -Non metastatic disease -ER- Negative, PR-Negative, and HER2-negative (triple-negative) Breast cancer
Exclusion criteria
Exclusion criteria: -Recurrent Breast cancer -Inability to give informed consent -Previous history of other cancers -Medical co morbidities precluding use of chemotherapy. -Concomitant malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare Pathological complete responses in both the groups.Timepoint: After completion of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the toxicity profile and chemotherapy completion rates (i.e. compliance) between the two groupsTimepoint: during chemotherapy, before completion of each cycle. | — |
Countries
India
Contacts
Public ContactDr Rakesh Kumar Mishra
Dr. B Borooah Cancer Institute
Outcome results
None listed