Omission of Surgery after Neoadjuvant Chemotherapy in Breast Cancer

Summary:

There is a potential for a paradigm shift in the way some early-stage breast cancer patients are treated. Currently, every breast cancer patient undergoing curative intent treatment requires surgery. However, for patients that achieved a complete response to pre-operative chemotherapy it may not be necessary. Surgery is associated with additional costs, time, and healthcare utilization, potential short-term complications, worse cosmetic outcomes, and may not provide a survival benefit for patients with an exceptional response to neoadjuvant (pre-operative) chemotherapy. There are several studies that found a large proportion of patients had no identifiable cancer at surgery because it was eradicated by neoadjuvant therapy. Some found it be as high as 65% for some subtypes of breast cancer. Patients with HER2-positive (HER2+) or triple-negative breast cancer (TNBC) may be the best candidates for omitting surgery as they have historically achieved higher complete response rates compared to other breast cancer subtypes.

While the investigators believe de-escalation is a reasonable approach in these patients, they will ensure that patients are not undertreated by requiring them to undergo a MRI, an image-guided biopsy, and a liquid biopsy via circulating tumor DNA (ctDNA). So only those with negative results for all three assessments, an enhanced clinical complete response, will be eligible to forego surgery and will solely receive radiation therapy to destroy any residual microscopic tumor cells. This phase I/II study will assess the recurrence rate of chemoradiation in patients with early-stage TNBC or HER2+ breast cancer (including node positive patients) that have exceptional responses to neoadjuvant chemotherapy compared to chemoradiation plus surgery. If the study is successful, it would permit thousands of patients to forego surgery, improving their quality of life and empower them to have a more active role in choosing their treatment.

Trial Registration: ClinicalTrials.gov Identifier: NCT07217990