Trial results investigating post-operative radiation with intensity-modulated radiation therapy (IMRT) in Stage IIB-III breast cancer were posted on ClinicalTrials.gov on 2025-06-13. The study, which enrolled 30 participants, reported 0 participants experiencing acute radiation effects, moderate-late pulmonary and cardiac effects, or local/regional recurrence.
Background
Stage IIB-III breast cancer often requires post-operative radiation therapy following mastectomy or breast-conserving surgery. Conventional radiation techniques, combined with chemotherapy, have demonstrated improved locoregional control and overall survival. However, these treatments can be associated with radiation-induced toxicities. Helical tomotherapy intensity-modulated radiation therapy (HT-IMRT) represents an advanced radiation technique designed to precisely target cancerous areas while minimizing radiation exposure to surrounding healthy tissues. This approach aims to potentially reduce treatment-related side effects in patients.
Trial design
This completed feasibility trial, designated as Phase NA, enrolled 30 participants with Breast Cancer, specifically Stage IIB-III. The study investigated the use of helical tomotherapy intensity-modulated radiation therapy (HT-IMRT) as a post-operative radiation technique. The primary objective was to assess the incidence of radiation-induced toxicity, with a goal of improving upon the results of conventional radiation by decreasing the amount of radiation-induced toxicity.
Key results
The trial collected several key measurements related to radiation effects and recurrence rates in the Helical Tomotherapy group:
- Acute Radiation Effects (Less Than 90 Days Post Treatment): 0 participants experienced acute radiation effects.
- Moderate-late Pulmonary and Cardiac Radiation Effects: 0 participants experienced moderate-late pulmonary and cardiac radiation effects.
- Rate of Local Recurrence: 0 participants experienced local recurrence.
- Rate of Regional Recurrence: 0 participants experienced regional recurrence.
What this means
The findings from this feasibility trial suggest that helical tomotherapy intensity-modulated radiation therapy (HT-IMRT) may be a well-tolerated treatment option for patients with Stage IIB-III breast cancer. The observation of 0 participants experiencing acute radiation effects, moderate-late pulmonary and cardiac effects, and local or regional recurrence is a significant positive signal from this small study. These results align with the trial's aim to decrease radiation-induced toxicity compared to conventional methods, while also indicating effective disease control within the study period. This data supports the potential for HT-IMRT to improve the quality of life for patients undergoing post-operative radiation for advanced breast cancer by minimizing treatment-related side effects.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT00508352, titled "Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer," were posted on 2025-06-13 on clinicaltrials.gov.