A groundbreaking clinical trial has revealed that surgery—long considered essential in breast cancer treatment—may be unnecessary for many early-stage breast cancer patients who respond completely to chemotherapy and radiation therapy.
Researchers at The University of Texas MD Anderson Cancer Center found that patients who achieved a pathologic complete response to neoadjuvant chemotherapy followed by standard radiation treatment remained cancer-free five years later, without undergoing surgery.
The phase II trial results, published in JAMA Oncology and presented at the Society of Surgical Oncology 2025 Annual Meeting, demonstrated a 100% overall survival rate among the 31 participants who had complete responses to initial treatment.
"The absence of detectable breast cancer recurrences at the five-year mark highlights the tremendous potential of this surgery-free approach to breast cancer management," said principal investigator Dr. Henry Kuerer, Professor of Breast Surgical Oncology at MD Anderson. "Our innovative, precise method of detecting cancer in these patients has successfully demonstrated that we can treat them while avoiding surgery for this group."
Study Design and Patient Population
The multicenter trial enrolled 50 women over age 40 with early-stage triple-negative or HER2-positive breast cancer. Of these participants, 21 had triple-negative breast cancer and 29 had HER2-positive breast cancer, with a mean age of 62 years.
All participants had undergone standard chemotherapy treatment and had a residual breast lesion less than 2 cm, as determined by imaging. Patients then received one image-guided vacuum-assisted core biopsy. If no disease was identified on the biopsy—indicating a pathologic complete response—surgery was omitted, and patients proceeded to standard whole-breast radiotherapy.
The vacuum-assisted core biopsy identified pathologic complete response in 31 patients, who then continued in the surgery-free protocol. After a median follow-up of 55.4 months, all of these patients remained disease-free.
No serious biopsy-related adverse events or treatment-related deaths occurred during the study period.
Historical Context and Significance
For more than a century, surgery has been the standard treatment for nonmetastatic invasive breast cancer. However, improved chemotherapy agents have significantly increased pathologic complete response rates in recent years.
This trial represents the first modern prospective study of surgery omission in patients with early-stage breast cancer who respond favorably to chemotherapy. It builds on earlier findings published in The Lancet Oncology with a shorter follow-up period of approximately two years.
"These continued promising results suggest that eliminating breast surgery for invasive breast cancer could become the new standard of care, offering women the opportunity to preserve their bodies," Dr. Kuerer explained.
Implications for Breast Cancer Treatment
Globally, 2.3 million women receive a breast cancer diagnosis every year. The researchers suggest that as many as 60% of early-stage breast cancers might be treatable without surgery, representing a paradigm shift in breast cancer management.
The approach combines high response rates to modern chemotherapy with selective image-guided vacuum-assisted core biopsy and stringent histologic processing, improving physicians' ability to determine which patients may not need surgery.
Dr. Kuerer emphasized that this surgery-free approach could significantly improve quality of life for breast cancer patients by allowing them to avoid invasive procedures while maintaining excellent oncologic outcomes.
Future Directions
While the results are promising, the researchers acknowledge limitations including the study's relatively small size and follow-up time. The multicenter trial has been expanded to include 100 patients and is currently being investigated further in South Korea.
"While we are hopeful that this approach will become routine, further clinical trials are necessary before this is a standard therapy," Dr. Kuerer cautioned.
The findings represent a potential turning point in breast cancer treatment, challenging long-held assumptions about the necessity of surgery and offering new hope for less invasive treatment options that maintain efficacy while reducing physical and psychological impact on patients.
