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A random allocation study to receive one of the trial intervention, to evaluate the safety of breast conserving surgery (surgery to remove cancer while leaving as much normal breast as possible) after giving neo adjuvant therapy in patients with locally advanced breast cancer (large tumors).

Phase 3
Conditions
Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: null- Proven Breast Cancer, who have received neo-adjuvant systemic therapy and are now deemed suitable for BCS
Registration Number
CTRI/2018/07/014767
Lead Sponsor
Tata Memorial Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

All women with biopsy proven T3/T4 Any N, Or Any T N2/N3 breast cancer who have received neo-adjuvant systemic therapy and are now deemed suitable for BCS

Women more than 18yrs

Patients who have given consent to participate in the study

Exclusion Criteria

Patients presenting to TMH, post excision Biopsy

Patients who show disease progression despite chemotherapy

Pregnant women/Lactating women.

Inflammatory Breast Cancer

Patients not keen on breast conservation.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Disease free survival at five yearsTimepoint: Disease free survival at five years
Secondary Outcome Measures
NameTimeMethod
Overall survival <br/ ><br>Quality of life <br/ ><br>Post NACT response patterns <br/ ><br>Timepoint: Overall survival will be measured untill death <br/ ><br>QOL will be measured at 5 time points <br/ ><br>and Post NACT response patterns will be taken care after completion of neo adjuvant chemotherapy
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