Breast Cancer, Cancer, Cancer of the Breast, ER+ Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONIntensity modulated radiation therapy (IMRT)
40 Gy total in 15 consecutive weekday sessions to the partial breast
Sponsors
Boca Raton Regional Hospital Foundation
Youssef Zeidan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Oncotype \< 26 (postmenopausal) \<16 (premenopausal), Low, or Ultra-Low index. * Minimum interval of 18 months from last breast radiotherapy session. * Prior radiation therapy in the form of brachytherapy, external beam MV photons, protons or intraoperative radiation are allowed with an upper total dose limit of 68 Gy (EQD2) for those patients with prior records available. * Ipsilateral recurrence, unifocal \< 3 cm with negative margins, N0, Tis and invasive (pathological staging) * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Planning target volume: whole breast (PTV: WB) ratio \< 1/2 * Life expectancy \> 12 months * Individuals able to become pregnant: agreement to use highly effective contraception starting at screening through treatment, and for 1 year after the end of PBI. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. A person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1. Has not undergone a hysterectomy or bilateral oophorectomy; or 2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time during the preceding 12 consecutive months)
Exclusion criteria
* BRCA1/2 mutation or any other receptor subtypes * Individuals assigned male at birth with breast cancer * Pregnancy or breastfeeding * Skin involvement * Distant metastasis * Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is not known, patients will still be allowed to enroll, and the initial primary tumor information will be recorded as missing on the clinical forms. * Other malignancies (except skin) * Connective tissue disorder (e.g., scleroderma, lupus) * Any other condition that may put a participant at higher risk, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of grade 3 or higher treatment-related adverse events (AEs) | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence-free survival (LRFS) | 5 years | 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) | 5 years | 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) | 5 years | 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) | 5 years | 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. |
| Change in patient-rated cosmesis | Over 5 years | Assessed using the National Surgical Adjuvant Breast and Bowel Project (NSABP) B39.0 questionnaire. Physical appearance. 22 questions, rated 1 (no difference between breasts) to 4 (large difference). Range 22-88 (worse). Recovery. 8 questions, rated 0 (not at all) to 10 (a lot). In 7 questions, higher is worse; scoring will be reversed for 1 item. Range 0-80 (worse). Feelings. 4 questions, rated 1 (all the time) to 5 (none of the time). Lower is better for 2 but worse for 2. Scoring for 2 items will be reversed. 4 questions related to pain rated from 0 (no pain) to 10 (worst pain). Range 0-40 (worse). One question is about pain treatment. Bothered. 27 questions, rated 0 (not at all) to 4 (very much). Range 0 -108 (worse). Satisfaction. Appearance of the treated breast rated from 1 (excellent) to 4 (poor). Satisfaction rated on a 5-item scale from totally satisfied to totally dissatisfied. Breast size before and after treatment: left larger, same, right larger. |
Countries
United States
Contacts
Primary ContactYoussef Zeidan, M.D., Ph.D.
Backup ContactMCI Multisite Research Program
Outcome results
None listed