Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Neoadjuvant chemotherapy with TAC (Docetaxel, Doxorubicin, Cyclophosphamide): Chemotherapy with inj. Docetaxel 75 mg/m2 iv in 500 ml normal saline iv infusion over 1 hour
and Inj Doxor
Sponsors
Dr ARYA SEN
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria a) Performance status less than or equal to 2 b) Age between 18 to 70 years c) Stage IIb and III by TNM Staging. Locally advanced breast carcinoma d) Patients with histopathologically proved invasive breast cancer with HER 2 score not more than 1, if HER 2 score is 2,then FISH study must come out to be negative for expression of the HER2 amplification gene e) Adequate cardiac function EF greater than 57% and fit for anthracycline and taxane based chemotherapy f) Total Serum billirubin should be less than 1.5 mg/dl g) Calculated serum creatinine clearance should be more than 60 ml/min/1.73m2 h) Informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria a) Patient had history of any other malignancy within last 5 years. c) Previously received previous radiotherapy and or chemotherapy d) Patients with uncontrolled co-morbid conditions like DM,HTN, e) Patients showing hypersensitivity to chemotherapeutic agents or its components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR defined as the absence of residual invasive cancer in the complete resected breast specimen and all sampled regional lymph nodes)Timepoint: At the end of Chemotherapy when surgery is being done | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess clinical tumor response to neoadjuvant chemotherapy Timepoint: Every 3 weeks;To assess the toxicity to NAC by CTCAE criteria v5 Timepoint: During & upto completion of Chemotherapy;Rate of Breast conservationTimepoint: At the time of Surgery;MRM rate in patients who had undergone NAC Timepoint: At the time of surgery;Disease free survival(DFS) post treatment Timepoint: at 1 year, 2 years;Overall survivalTimepoint: at 1 year & 2 years | — |
Countries
India
Contacts
Public ContactPROF. DR. AMITABHA MANNA
IPGMER and SSKM Hospital
Outcome results
None listed