To see the effect of INj proluton if given before surgery in patients with high risk operable breast cancer.�
Phase 3
Not yet recruiting
- Conditions
- Health Condition 1: null- High risk operable breast cancer
- Registration Number
- CTRI/2014/10/005098
- Lead Sponsor
- Tata memorial hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 860
Inclusion Criteria
1 Patients willing to provide informed consent.
2 Women 18 years of age or more.
3 Operable Breast cancer patients with clinically or radiologically node positive disease
Exclusion Criteria
1 Patients with a prior history of any malignancy.
2 Patient with a prior history of excision biopsy.
3 Patient receiving preoperative chemotherapy
4 Women who are pregnant, breast-feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To see the effect of single dose of preoperative Inj. Proluton (Hydroxyprogesterone caproate) on disease-free survival (DFS) at 5 years.Timepoint: 5 years
- Secondary Outcome Measures
Name Time Method To see the effect of single dose of preoperative Inj. Proluton (Hydroxyprogesterone caproate) on overall survival (OS) at 5 yearsTimepoint: 5 yrs