Comparing two types of chemotherapy in breast cancer
- Conditions
- Health Condition 1: null- Breast cancer
- Registration Number
- CTRI/2017/10/010272
- Lead Sponsor
- Jawaharlal Institute of Post Graduate Medical Education and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Newly diagnosed, Histologically confirmed Triple negative Breast cancer ER <1%, PR <1% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH negative].
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method