eo Adjuvant Chemotherapy in Triple Negative Breast Cancer
Phase 3
- Conditions
- Health Condition 1: null- Locally advanced or Large Operable Breast cancer patients with Triple Negative hormone receptor status.Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2012/07/002802
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age 18-70 years
2.All women patients with triple negative hormone status
planned for neoadjuvant chemotherapy
3.Patients with adequate baseline marrow function defined as
ANC > 1500/mm3 and Platelet count > 1, 00,000/mm3.
4.Patients with acceptable liver function tests (normal bilirubin and AST/ALT < 2 times the upper limit of normal) and normal renal function tests at baseline
5.Patients willing to provide informed consent
6.Patients fit for chemotherapy
Exclusion Criteria
1. Prior excision biopsy
2. Metastatic breast cancer
3. Women with inflammatory breast cancer
4. Poor cardiac function at baseline with LVEF <40%
5. Patients with a prior history of a malignancy
6. Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To see the effect of addition of platinum based chemotherapy on disease free and overall survival and response rates in triple negative breast cancer.Timepoint: 5 years after completion of accrual
- Secondary Outcome Measures
Name Time Method ot AnyTimepoint: Not Any