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

PROPOSED TOPIC OF RESEARCH: OUTCOME OF NEOADJUVANT CHEMOTHERAPY ON OPERABLE LOCALLY ADVANCED BREAST CARCINOMA: A RANDOMIZED CONTROLLED TRIAL

OBJECTIVE:

To assess the role of neoadjuvant chemotherapy on operability and local control of operable locally advanced breast carcinoma.

BACKGROUND OF THE PRESENT STUDY:

Breast cancer is the most common site-specific cancer in women and is leading cause of death from cancer for women aged 20 to 59 years. Locally advanced breast cancer is a subset of breast cancer characterized by the most advanced breast tumours in the absence of distant metastasis. LABC are divided into operable and inoperable types. For operable LABC, radical surgery is routine intervention accompanied with post-operative chemotherapy and radiotherapy, and pre-operative neoadjuvant chemotherapy (NAC) is rather optional for breast conservation purposes. For inoperable LABC preoperative neoadjuvant chemotherapy is required. Preoperative neoadjuvant chemotherapy reduces tumour size or lymph node status or both. The purpose of the study to assess the role of

neoadjuvant chemotherapy on operability and local control of operable locally advanced breast carcinoma.

METHODOLOGY:

This study will be conducted on the patients attending emergency and out-patient Department of General Surgery and Department of Radiotherapy in Medical college and Hospital, Kolkata. A detailed history, thorough physical examinations, investigation are the basis of study. The diagnosis of primary breast cancer will be determined by Trucut Biopsy in intervention arm and FNAC will be sufficient to diagnose breast cancer in control arm. Lymph node metastasis will be confirmed by USG & USG guided FNAC. Receptor status before neoadjuvant chemotherapy (NAC) will be analysed. After completion of all clinical evaluation and investigations all eligible patient will be randomly divided into intervention and control arms, using Sequentially Numbered Opaque Sealed Envelopes Technique. Intervention arm will receive neoadjuvant chemotherapy of three cycles of 5-Fluorouracil, Adriamycin and Cyclophosphamide followed by surgery. Control arm will be assigned for upfront surgery.

The response to chemotherapy will be studied in all patients who received neo-adjuvant chemotherapy according to revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), and will be classified into i) ‘Complete response’, ii) ‘Partial Response’, iii) ‘Progressive Disease’ and iv) ‘Stable Disease’

Then surgery will be performed. Post-Surgery ypTNM staging in intervention arm and pTNM staging in control arm along with HPE report will be compared. Wound complication - a) Flap Necrosis, b) Seroma after removal of drain after 5 days or until drainage diminishes to <30mL/day for two consecutive day and c) Wound Healing Time will also be compared to the both arms of our study. All the Data will be stored and after completion of data collection all the data will be analysed.

EXPECTED OUTCOME:

This study is expected to find that neoadjuvant chemotherapy will help in local control and operability of operable locally advanced breast carcinoma.