Neoadjuvant Therapy for Breast Cancer

(NoCUT-BC Trial)

This trial tests whether a new non-surgical approach is as effective as traditional surgery for treating locally advanced breast cancer. Participants will receive neoadjuvant chemotherapy (chemotherapy given before other treatments) to determine if their cancer responds well enough to avoid surgery. Those who respond well will receive radiation and monitoring, while others will undergo surgery followed by radiation. This trial suits individuals with early-stage breast cancer who plan to start chemotherapy and radiation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new approach.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Neoadjuvant chemotherapy, often used for breast cancer, is generally well-tolerated by patients, as studies have shown. Research indicates that this treatment can effectively shrink tumors before surgery, making the procedure easier or sometimes even unnecessary.

Real-world evidence shows that combining neoadjuvant chemotherapy with pembrolizumab, a medicine that boosts the immune system, is a standard approach for certain types of breast cancer. This combination has been used safely, with many patients experiencing a reduction in tumor size.

Researchers are excited about this trial because it explores an innovative approach to treating breast cancer by using neoadjuvant chemotherapy in a way that could reduce the need for surgery. Unlike the traditional method where all patients typically undergo surgery after chemotherapy, this trial evaluates the effectiveness of neoadjuvant chemotherapy to potentially achieve an enhanced clinical complete response (ecCR) that might eliminate the need for surgery altogether. This could mean that patients who respond well to the chemotherapy might avoid surgical procedures and instead receive radiation therapy, which could lead to less invasive treatment options and a better quality of life. Additionally, for those who do not achieve ecCR, the trial examines the combination of surgery with chemotherapy, potentially refining and personalizing treatment plans for better outcomes.

Research has shown that starting chemotherapy before surgery, known as neoadjuvant chemotherapy, can effectively treat advanced breast cancer. Over the past 20 years, improvements in these treatments have greatly increased patient survival rates. One study found that more than 97% of patients experienced noticeable tumor shrinkage. Another study noted that while not all tumors disappeared completely, many patients experienced significant tumor reduction. In this trial, participants will receive standard-of-care neoadjuvant chemotherapy. Those who achieve an enhanced clinical complete response (ecCR) will enter the non-surgical arm and receive radiation therapy. Participants who do not achieve an ecCR will enter the surgical arm and undergo a lumpectomy or mastectomy, followed by radiation therapy. These findings suggest that neoadjuvant chemotherapy is a promising way to shrink tumors before other treatments like surgery or radiation.¹⁴⁶⁷⁸