Trial results for a study on preoperative single-fraction radiotherapy in early-stage breast cancer were posted on 2026-03-17. The Phase 2 study enrolled 110 participants to evaluate cosmesis following this treatment approach.
Background
Breast cancer treatment often involves a combination of therapies, including surgery and radiation. Conventional radiation therapy typically requires multiple sessions over several weeks. This trial explored the efficacy and cosmetic outcomes of a preoperative single-fraction radiotherapy, building upon earlier phase findings. The investigation aimed to assess the feasibility of delivering a single 21Gy dose preoperatively to a larger patient group and to evaluate cosmetic results, which are a key aspect of patient quality of life after breast cancer treatment.
Trial design
This Phase 2, single-arm study (NCT02482376) enrolled 110 participants diagnosed with Breast Cancer. The intervention consisted of preoperative administration of 21Gy as a single fraction of stereotactic radiotherapy. The primary objective was to determine physician-reported rates of good/excellent cosmesis at baseline and at 6 months, 1, 2, and 3 years post-treatment, as assessed by the NRG cosmesis scale.
Key results
The trial collected data on both physician and patient-reported cosmetic outcomes for the Single Arm 21Gy Stereotactic Radiotherapy group:
- Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis: The observed counts of participants reporting good/excellent cosmesis at various assessment points were 64, 59, 58, and 56 participants.
- Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis: The observed counts of participants reporting good/excellent cosmesis at various assessment points were 67, 62, 60, 60, and 53 participants.
What this means
The results from this Phase 2 study indicate that a substantial number of participants experienced favorable cosmetic outcomes after receiving preoperative single-fraction radiotherapy for early-stage breast cancer. Both physician and patient perspectives consistently reported good or excellent cosmesis across different evaluation periods. These findings suggest that the 21Gy single-fraction approach could be a promising treatment option, potentially offering a more streamlined and convenient radiation schedule while maintaining acceptable aesthetic results, which is an important consideration for patient satisfaction and recovery.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02482376, titled "Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer", were posted on 2026-03-17 on clinicaltrials.gov.