Dr. Chirag Shah, a radiation oncologist at the Cleveland Clinic’s Department of Radiation Oncology and co-director of the Comprehensive Breast Program, has outlined ongoing clinical trials aimed at minimizing surgical interventions in the treatment of patients with locoregional breast cancer.
One significant trial highlighted by Shah is the recently published SOUND trial (NCT02167490), which explored the omission of sentinel lymph node biopsies in early-stage breast cancer patients who had negative results on preoperative axillary lymph node ultrasonography. The trial seeks to identify subsets of patients who can safely undergo reduced surgical procedures without compromising outcomes. Results indicated that omitting sentinel lymph node biopsy was noninferior in terms of distant disease-free survival (DDFS), with a 5-year DDFS rate of 98.0% in the no auxiliary surgery group compared to 97.7% in those who underwent biopsy.
Shah also discussed ongoing trials investigating reductions in radiation therapy for early-stage breast cancer patients. He emphasized the phase 3 DEBRA trial (NCT04852887), which utilizes the Oncotype DX assay to identify patients who may not require radiation therapy after lumpectomy. This trial aims to personalize treatment plans based on genetic profiling, potentially sparing patients from unnecessary radiation and its associated toxicities.
In addition, Dr. Shah mentioned Cleveland Clinic’s involvement in a phase 2 study (NCT06129747) evaluating once-daily radiation therapy following repeat breast-conserving surgery.
Furthermore, efforts are being made to address the necessity of lymph node radiation. Dr. Shah pointed to the phase 3 CCTG MA.39 trial (NCT03488693), also employing the Oncotype DX assay, which examines the omission of regional radiotherapy in patients with biomarker low-risk, node-positive, T3N0 breast cancer.
These trials represent critical steps toward refining treatment strategies for breast cancer patients, aiming to reduce unnecessary surgeries and tailor therapies based on individual risk profiles and genetic markers.
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