Eliminating Breast Surgery for Invasive Cancer with Exceptional Response to Neoadjuvant Systemic Therapy: Prospective Multicenter Clinical Trial Planned Initial Feasibility Endpoint

Authors

Helen M Johnson
Vicente Valero
Wei T Yang
Benjamin D Smith
Savitri Krishnamurthy
Yu Shen
Heather Lin
Anthony Lucci
Gaiane M Rauch
Henry M Kuerer

Publication Date

7-1-2023

Journal

Journal of the American College of Surgeons

Abstract

Background: Response to neoadjuvant systemic therapy (NST) for breast cancer enables tailoring of subsequent therapy. Image-guided breast biopsy after NST can accurately predict a pathologic complete response (pCR). The feasibility phase of the clinical trial reported here assesses omission of breast surgery followed by radiotherapy in terms of local recurrence before trial expansion.

Study design: Women with unicentric, cT1-2 N0-1 M0 triple-negative (TNBC) or human epidermal growth factor receptor 2-positive breast cancer (HER2+BC) cancer with < 2 cm residual disease on post-NST imaging were eligible to enroll. If no residual invasive or in situ disease was identified by image-guided, vacuum-assisted core biopsy (VACB), breast surgery was omitted, and radiotherapy delivered. The primary endpoint for the feasibility phase was ipsilateral breast tumor recurrence at 6 months. If any recurrence occurred during the feasibility phase the trial would halt.

Results: Thirteen patients were enrolled from March 2017 to October 2018. The mean age was 60.8 years (range 51 to 75) and most patients were White (69.2%) and non-Hispanic/Latino (84.6%). All patients had invasive ductal carcinoma (6 TNBC, 7 HER2+BC). Mean tumor size was 2.4 cm (range 0.9 to 5.0) before NST and 0.7 cm (range 0 to 1.8) after NST. Seven patients (53.8%) had residual disease identified on VACB; the remaining 6 (46.2%) comprised the feasibility cohort. At a median follow-up of 44.3 months (range 41.3 to 51.3) there was no ipsilateral breast tumor recurrence in this cohort.

Conclusions: These early data suggest that omission of breast surgery in patients with invasive TNBC and HER2+BC with no evidence of residual disease on standardized VACB after NST is potentially feasible. Results from the expansion phase of this clinical trial will be reported per protocol prespecified analyses.

Keywords

Female, Humans, Middle Aged, Aged, Neoadjuvant Therapy, Triple Negative Breast Neoplasms, Prospective Studies, Feasibility Studies, Neoplasm Recurrence, Local, Breast Neoplasms, Receptor, ErbB-2, Antineoplastic Combined Chemotherapy Protocols

DOI

10.1097/XCS.0000000000000670

PMID

36856291

PMCID

PMC11892649

PubMedCentral® Posted Date

3-10-2025

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes