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OUTCOME OF CHEMOTHERAPY GIVEN BEFORE OPERATION ON OPERABLE LOCALLY ADVANCED BREAST CANCER: A CLINICAL TRIAL

OUTCOME OF NEOADJUVANT CHEMOTHERAPY ON OPERABLE LOCALLY ADVANCED BREAST CARCINOMA: A RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034456
Enrollment
50
Registered
2021-06-29
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

Interventions

Intervention1: Neoadjuvant Chemotherapy followed by Surgery: Neoadjuvant Chemotherapy of four cycles of 5-Fluorouracil, Adriamycin and Cyclophosphamide
Surgery: Modified Radical Mastectomy or Breast Conservation Surgery Control Intervention1: Upfront Surgery: Surgery: Modified Radical Mastectomy or Breast Conservation Surgery

Sponsors

Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Willing to give written informed consent and to follow the study procedure. 2) Non-pregnant / non-lactating female patient. 3) The patients belong to operable locally advanced breast carcinoma (T3N1-2M0, T4bN0-1M0)

Exclusion criteria

Exclusion criteria: 1) Patients with metastatic disease. 2) Patients refused to give consent and to follow the study procedure.

Design outcomes

Primary

MeasureTime frame
To assess efficacy of Neoadjuvant chemotherapy for decreasing tumour size or lymph node status or both by RECIST criteriaTimepoint: 4 weeks—

Secondary

MeasureTime frame
Post operative flap necrosisTimepoint: 4 weeks after Operation;Post operative Seroma formationTimepoint: 4 weeks after Operation;Post operative SSI (Surgical Site Infection)Timepoint: 4 weeks after Operation—

Countries

India

Contacts

Public ContactDr Rajib Sardar

Medical College Kolkata

dr.rathinsarkar@gmail.com9433138964

Outcome results

None listed

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