Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT06008158
Brief Summary:
This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year after completion of APBI QD.
SECONDARY OBJECTIVES:
I. To determine the long-term patient-reported cosmetic appearance of the breast in patients treated with APBI QD.
II. To determine the short-term and long-term physician reported cosmetic appearance of the breast in patients treated with APBI QD.
III. To determine the acute and late patient-reported radiation toxicity of APBI QD.
IV. To determine the acute and late physician-reported radiation toxicity of APBI QD.
V. To determine the cancer control outcomes of APBI QD.
EXPLORATORY OBJECTIVES:
I. To assess the health-related quality of life in patients treated with APBI QD.
II. To determine the long-term blinded physician review of cosmetic appearance of the breast in patients treated with APBI.
III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD.
OUTLINE:
Patients undergo APBI QD on consecutive business days for 5 treatments.
Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years post-APBI.
Study:
NCT06008158
Study Brief:
Protocol Section:
NCT06008158