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Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Randomized trial comparing neo-adjuvant versus adjuvant chemotherapy in operable locally advanced breast cancer (T4b
S V S Deo1, Manisha Bhutani, Nootan K Shukla
1Department of Surgical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India. svsdeo@yahoo.co.in
Background And Objectives:
Locally advanced breast cancer (LABC) remains a major problem in developing countries. While trials utilizing neo-adjuvant chemotherapy demonstrate superior survival rates compared to historic controls, randomized studies evaluating the precise role of neo-adjuvant chemotherapy in LABC are lacking. In the present trial, neo-adjuvant chemotherapy was compared against adjuvant chemotherapy to assess survival advantage in operable T4b N0-2 M0 breast cancer.
Methods:
A total of 101 women with operable LABC (T4b N0-2 M0) were randomized. In arm A, 50 patients received 3 cycles of CEF chemotherapy before and 3 cycles following surgery. In arm B, 51 patients had primary surgery followed by 6 cycles of CEF chemotherapy. In both arms, loco-regional radiotherapy was given after completion of CEF.
Results:
The response of primary tumor to neo-adjuvant chemotherapy was 66%, complete response (CR) 14% and partial response (PR) 52%. Clinical nodal response occurred in 95% of node positive patients. Only two (4%) patients had pathologic CR both in tumor and axilla. There was a significant (P = 0.02) increase in incidence of pathologically negative nodes in arm A. At a median follow up of 25 months, there was no significant difference in overall and disease free survival (DFS) in both arms (P = 0.42 and 0.18). Patients showing a response to neo-adjuvant chemotherapy had better DFS (P = 0.04) compared to those who had no response.
Conclusions:
Early results of the study indicate no survival benefit with the inclusion of neo-adjuvant chemotherapy in LABC (T4b N0-2 M0). Neo-adjuvant chemotherapy resulted in significant down staging; good responders had a better DFS compared to those who did not respond.
