An open label, phase 3 randomized trial to evaluate the role of axillary conservation surgery in breast cancer patients post-neoadjuvant chemotherapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 2,316
- Locations
- 1
- Primary Endpoint
- To show the non-inferiority of DFS between axillary conservative surgery (defined further as
Study Overview
Brief Summary
Patients with breast cancer are routinely treated with surgery for the breast and axilla. In the early node negative breast cancer setting, it is acceptable to carry out a sentinel node biopsy (SNB) or equivalent axillary staging procedure such as low axillary sampling (LAS) which has been shown to be not inferior with respect to long term survival as well as axillary nodal recurrence. Axillary conservation procedure is also likely to reduce the incidence of side effects of a complete axillary lymph node dissection. This procedure is acceptable only if axillary lymph nodes are negative on pathology. In our setting, almost 50% patients have positive nodes in the axilla. Nearly 40-50% patients whether locally advanced or operable with poor breast/tumour ratio receive neoadjuvant or pre-operative chemotherapy. In nearly 50-60% of such patients, axilla is rendered negative by chemotherapy. These patients who have good response to chemotherapy are ideal candidates to receive limited axillary surgery post-chemotherapy. However, the long-term effect of conserving the axilla is not yet proven in these patients. Hence, the study we are submitting will assess the feasibility of limited axillary nodal surgery in patients of breast cancer who have negative axillary nodes post-chemotherapy
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
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
- •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.
Outcomes
Primary Outcomes
To show the non-inferiority of DFS between axillary conservative surgery (defined further as
Time Frame: At each follow up visit till completion of 5 years
low axillary sampling or equivalent sentinel node biopsy procedure) as compared to complete
Time Frame: At each follow up visit till completion of 5 years
axillary lymph node dissection in patients who are rendered node negative clinically after neoadjuvant chemotherapy
Time Frame: At each follow up visit till completion of 5 years
Secondary Outcomes
- 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)