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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).

A randomized controlled trial to evaluate the safety of breast conserving surgery post neoadjuvant therapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014767
Enrollment
2624
Registered
2018-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: null- Proven Breast Cancer, who have received neo-adjuvant systemic therapy and are now deemed suitable for BCS

Interventions

Intervention1: Breast conservation surgery (with or without reconstruction): Eligible patients will be randomized Intervention arm will undergo Breast Conservation surgery with or without reconstructi

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Disease free survival at five yearsTimepoint: Disease free survival at five years

Secondary

MeasureTime frame
Overall survival Quality of life Post NACT response patterns Timepoint: Overall survival will be measured untill death QOL will be measured at 5 time points and Post NACT response patterns will be taken care after completion of neo adjuvant chemotherapy

Countries

India

Contacts

Public ContactShabina

Tata Memorial Hospital

nitanair@hotmail.com09821354102

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026