Health Condition 1: null- Breast cancer
Conditions
Interventions
Intervention1: Group DC: Inj Docetaxel 75 mg/m2 IVF D1over 1 hr and Inj Carboplatin AUC 6 IVF D1over 1 hr once every 21 days. A total of six cycles will be administered.
Control Intervention1: Group
Sponsors
Jawaharlal Institute of Post Graduate Medical Education and research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed, Histologically confirmed Triple negative Breast cancer ER 2. Stages 2 and 3 according to AJCC edition7,( see appendix 1. ) 3. Has provided written Informed Consent for participation in this trial 4. Adequate Haematological, renal, hepatic and pulmonary functions as defined by, examples ï?? Absolute neutrophil count (ANC, segs + bands), 1.5 x 109/L ï?? Platelet count, 100 x 109/L ï?? Total bilirubin, 1.5 x upper normal ï?? Alanine aminotransferase (ALT), 2.5 x upper normal limit ï?? Calculated creatinine clearance > 60ml/min (Cockcroft-Gault formula ) 5. An ECOG performance status score of [0,1] 6. Participants capable of childbearing are using adequate contraception 7. Available for follow up
Exclusion criteria
Exclusion criteria: 1. Male Breast cancer 2. Her2 neu 2+ but not confirmed with FISH 3. Women who are pregnant or lactating. 4. Past or current history of another malignancy 5. Previous radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete response (pCR)- absence of residual invasive and. in situ cancer on hematoxylin and eosin evaluation of the complete resected breast. specimen and all sampled regional lymph nodes following completion of neoadjuvant chemotherapy.Timepoint: End of chemotherapy and post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective Tumour response 2. Disease free survival 3. Overall survival 4. Adverse events Timepoint: 1. Objective Tumour response at end of all cycles of chemotherapy 2. Disease free survival at 3 years 3. Overall survival at 3 years | — |
Countries
India
Contacts
Public ContactBiswajit Dubashi
JIPMER
Outcome results
None listed