Breast Re-irradiation After Second Ipsilateral Lumpectomy
BRASIL
1 other identifier
interventional
114
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Oct 2025
Longer than P75 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedStudy Start
First participant enrolled
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2033
November 13, 2025
November 1, 2025
2.5 years
March 5, 2025
November 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (5)
Local recurrence-free survival (LRFS)
5 years
Overall survival (OS)
5 years
Distant metastasis-free survival (DMFS)
5 years
Mastectomy-free survival (MFS)
5 years
Change in patient-rated cosmesis
Over 5 years
Study Arms (1)
Partial Breast Irradiation (PBI)
EXPERIMENTALInterventions
40 Gy total in 15 consecutive weekday sessions to the partial breast
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Youssef Zeidanlead
- Boca Raton Regional Hospital Foundationcollaborator
Study Sites (2)
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, 33486, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Related Publications (3)
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.
PMID: 31750868BACKGROUNDArthur 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.
PMID: 28721885BACKGROUNDOlivotto 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.
PMID: 23835717BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youssef Zeidan, M.D., Ph.D.
Lynn Cancer Institute at Baptist Health, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Radiation Oncologist
Study Record Dates
First Submitted
March 5, 2025
First Posted
March 10, 2025
Study Start
October 27, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2033
Last Updated
November 13, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share