Health Condition 1: C50-C50- Malignant neoplasms of breast Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Only low axillary sampling OR sentinel node biopsy: Patients on the experimental arm would undergo low axillary sampling OR sentinel node
biopsy instead of total axillary clearance as p
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1 Histopathologically proven Breast Cancer 2 All patients with non metastatic breast cancer cT1 to 4 cN0 to 2 before beginning neoadjuvant chemotherapy 3 Post NACT cN0 4 Patient voluntarily willing to give consent for study
Exclusion criteria
Exclusion criteria: 1 Inflammatory breast cancer 2 Recurrent disease 3 Pregnant and lactating patients 4 Metastatic disease (including oligometastasis) 5 Pre-chemotherapy cN3 status (supraclavicular lymph node involvement and or internal mammary lymph node involvement) 6 Women who have received prior chemo or hormonal therapy for breast cancer or co-existing or previously treated non breast malignancy (such as hematolymphoid or ovarian cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show the non-inferiority of DFS between axillary conservative surgery (defined further as low axillary sampling or equivalent sentinel node biopsy procedure) as compared to complete axillary lymph node dissection in patients who are rendered node negative clinically after neoadjuvant chemotherapyTimepoint: At each follow up visit till completion of 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To show a reduction in arm and shoulder morbidity with low axillary sampling To assess the difference between the rate of regional nodal recurrence rate, local recurrence, distal recurrence To compare the overall survival in the two groups To assess the RT dose delivered to axilla in both arms by proper dosimetric studiesTimepoint: Assessment will be done at each followup visit till completion of 5 years of treatment completion | — |
Countries
India
Contacts
Public ContactDr Shalaka P Joshi
Tata Memorial Hospital
Outcome results
None listed