Recruiting NCT06867484
Breast Re-irradiation After Second Ipsilateral Lumpectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensity modulated radiation therapy (IMRT).
- Who it may be relevant to
- Registry conditions: Breast Cancer, Cancer, Cancer of the Breast, HER2-negative Breast Cancer. Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)
Overview
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
- Radiation Intensity modulated radiation therapy (IMRT)
40 Gy total in 15 consecutive weekday sessions to the partial breast
Primary outcome measures
- Rate of grade 3 or higher treatment-related adverse events (AEs) [Time frame: 1 year]
Secondary outcome measures (5)
- Local recurrence-free survival (LRFS) [Time frame: 5 years]
- Overall survival (OS) [Time frame: 5 years]
- Distant metastasis-free survival (DMFS) [Time frame: 5 years]
- Mastectomy-free survival (MFS) [Time frame: 5 years]
- Change in patient-rated cosmesis [Time frame: Over 5 years]
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:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Lynn Cancer Institute at Baptist Health, Inc. — Boca Raton
- Miami Cancer Institute at Baptist Health, Inc. — Miami
Publications
- 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 PMID 31750868
- 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- PMID 28721885
- 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 PMID 23835717
Identifiers
NCT: NCT06867484 · LCI-2023-ZEI-001