Clinical trial NCT06867484: Breast Re-irradiation After Second Ipsilateral Lumpectomy
Official title: Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Cancer
Cancer of the Breast
HER2-negative Breast Cancer
ER+ Breast Cancer
Estrogen-receptor-positive Breast Cancer
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Boca Raton Regional Hospital Foundation
First posted: 2025-03-10
Enrollment: 114
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of grade 3 or higher treatment-related adverse events (AEs)
timeFrame: 1 year
Secondary outcomes:
measure: Local recurrence-free survival (LRFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Distant metastasis-free survival (DMFS)
timeFrame: 5 years
measure: Mastectomy-free survival (MFS)
timeFrame: 5 years
measure: Change in patient-rated cosmesis
timeFrame: Over 5 years
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Lynn Cancer Institute at Baptist Health, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc.
state: Florida
Study officials:
affiliation: Lynn Cancer Institute at Baptist Health, Inc.
name: Youssef Zeidan, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.
citation: Arthur DW, Winter KA, Kuerer HM, Haffty BG, Cuttino LW, Todor DA, Simone NL, Hayes SB, Woodward WA, McCormick B, Cohen RJ, Sahijdak WM, Canaday DJ, Brown DR, Currey AD, Fisher CM, Jagsi R, White J. NRG Oncology-Radiation Therapy Oncology Group Study 1014: 1-Year Toxicity Report From a Phase 2 Study of Repeat Breast-Preserving Surgery and 3-Dimensional Conformal Partial-Breast Reirradiation for In-Breast Recurrence. Int J Radiat Oncol Biol Phys. 2017 Aug 1;98(5):1028-1035. doi: 10.1016/j.ijrobp.2017.03.016. Epub 2017 Mar 18.
citation: Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.