Role of core biopsy to predict complete response in the breast after preoperative chemotherapy - CRBr study
Phase 2
- Conditions
- Health Condition 1: null- Breast cancer
- Registration Number
- CTRI/2018/01/011122
- Lead Sponsor
- Basavatarakam Indo American Cancer Hospital Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients willing to provide informed consent
2. Patients with newly diagnosed non metastatic breast cancer who have no clinically or radiologically demonstrable disease following neoadjuvant chemotherapy as seen on a mammogram and ultrasound of the breast.
Exclusion Criteria
1. Patients with prior history of any malignancy
2. Patients with excision biopsy of the breast primary
3. Patients undergoing upfront surgery
4. Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method False negative rate of multiple core biopsies in predicting pathological complete responseTimepoint: 18 months
- Secondary Outcome Measures
Name Time Method Accuracy, positive and negative predictive value of multiple core biopsies in predicting pathological complete responseTimepoint: 18 months;Exploratory analysis between the multiple core biopsies,pathological complete response in the breast and pathological complete response in the axillaTimepoint: 18 months;Planned subgroup analysis for the false negative rate in triple negative and HER2 positive breast cancersTimepoint: 18 months