The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.
Diagnosed with ER+HER2- breast cancer
Provision of signed and dated ICF
Stated willingness to comply with all study procedures and availability for the duration of the study
Age ≥ 40 years
BRCA1/2 mutation or any other receptor subtypes
Individuals assigned male at birth with breast cancer
Pregnancy or breastfeeding
Skin involvement
Single group
Intensity modulated radiation therapy (IMRT)
Radiation40 Gy total in 15 consecutive weekday sessions to the partial breast
Rate of grade 3 or higher treatment-related adverse events (AEs)
Adverse events will be collected using Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) starting from the first radiation treatment. Grade 1 AEs are considered mild, grade 2 AEs are considered moderate, grade 3 AEs are considered severe, grade 4 AEs are considered life-threatening, and grade 5 AEs are considered fatal. The percentage of participants experiencing grade 3 or higher treatment-related AEs will be calculated.
Local recurrence-free survival (LRFS)
Local recurrence is defined as tumor recurrence in the reirradiated region. LRFS is defined as time from the start of radiation treatment to local recurrence or death, whichever occurs first, and will be estimated by Kaplan-Meier method. Participants who do not have local recurrence and are still alive will be censored to their final follow-up date.
Overall survival (OS)
OS is defined as the time from the start of radiation treatment to death and will be estimated by Kaplan-Meier method. Participants who are still alive will be censored to their final follow-up date.
Distant metastasis-free survival (DMFS)
Distant metastasis is defined as cancer spreading to other areas of the body. DMFS is defined as the time from the start of radiation treatment to time of distant metastasis or death and will be estimated by Kaplan-Meier method. Participants who do not have distant metastasis and are still alive will be censored to their final follow-up date.
Mastectomy-free survival (MFS)
MFS is defined as the time from the start of radiation treatment to mastectomy or death, whichever occurs first, and will be estimated by Kaplan-Meier method. Participants who have not had a mastectomy and are still alive will be censored to their final follow-up date.
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Youssef Zeidan
Lead sponsor
Baptist Health South Florida
Sponsor institution
Boca Raton Regional Hospital Foundation
Collaborator
