Selective Elimination of Breast Surgery for Invasive Breast Cancer: A Nonrandomized Clinical Trial

Area of Science:

• Oncology
• Surgical Oncology
• Radiotherapy

Background:

• Neoadjuvant systemic therapy (NST) achieves pathologic complete response (pCR) in up to 60% of breast cancers (BCs).
• The necessity of breast surgery after successful NST is increasingly questioned.
• Image-guided vacuum assisted biopsy (VAB) can assess residual disease after NST.

Purpose of the Study:

• To evaluate the 5-year efficacy of radiotherapy alone without breast surgery in select breast cancer patients post-NST.
• To determine the rate of ipsilateral breast tumor recurrence in patients treated with non-surgical methods.

Main Methods:

• A single-arm, prospective, phase 2 clinical trial involving women with cT1-2N0-1M0 ERBB2-positive or triple-negative invasive BC.
• Patients with residual lesions <2 cm after NST underwent image-guided VAB.
• Selected patients achieving breast pCR on VAB received whole-breast radiotherapy with a boost, omitting surgery.

Main Results:

• Of 50 patients, 31 (62%) achieved breast pCR on VAB.
• At a median follow-up of 55.4 months, 0% ipsilateral breast tumor recurrence was observed.
• Disease-free and overall survival rates were 100% in patients not undergoing breast surgery.

Conclusions:

• Omission of breast surgery following NST and VAB appears feasible in select breast cancer patients.
• This non-surgical approach demonstrated excellent short-term oncologic outcomes.
• Further confirmatory studies are required to integrate this approach into standard surgical practice.