AzTrials
AzTrials

Breast CancerBRASILNCT06867484

Breast Re-irradiation After Second Ipsilateral Lumpectomy

A study testing Intensity modulated radiation therapy (IMRT) in people with Breast Cancer and Cancer, run by Youssef Zeidan at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Cancer, Cancer, Cancer of the Breast
What is being tested?
Intensity modulated radiation therapy (IMRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
2 sitesUnited States
Study dates
27 Oct 2025to May 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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)

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Youssef Zeidan, M.D., Ph.D. contact

(561) 955-5966

youssef.zeidan@baptisthealth.net

MCI Multisite Research Program contact

MCIMultiSiteResearch@baptishealth.net

United States2 sites, 2 recruiting

  • Lynn Cancer Institute at Baptist Health, Inc.

    Boca Raton, Florida, 33486

    Youssef Zeidan, M.D., Ph.D., (561) 955-5966, youssef.zeidan@baptisthealth.net

    MCI Multisite Research Program, MCIMultiSiteResearch@baptishealth.net

    Recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

    Joseph Panoff, M.D., (786) 596-2000, josephpa@baptisthealth.net

    MCI Multisite Research Program, MCIMultiSiteResearch@baptishealth.net

    Recruiting

Other trials in United States

About this study

Official title: Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)

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.

Being tested
Intensity modulated radiation therapy (IMRT)
Medical subject headings
Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity modulated radiation therapy (IMRT)Radiation

    40 Gy total in 15 consecutive weekday sessions to the partial breast

Study groups in NCT06867484
Study groupRoleWhat they receive
Partial Breast Irradiation (PBI)ExperimentalNot described
Receives: Radiation: Intensity modulated radiation therapy (IMRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (5)

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. 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.

    Measured: 5 years

  4. 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.

    Measured: 5 years

  5. Change in patient-rated cosmesis

    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.

    Measured: Over 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start27 Oct 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06867484
Sponsor's protocol ID
LCI-2023-ZEI-001
Acronym
BRASIL
Status last verified
Nov 2025
First submitted
5 Mar 2025
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.

    PubMed 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-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.

    PubMed 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):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.

    PubMed 23835717

Questions about this trial

What is this clinical trial studying?

A study testing Intensity modulated radiation therapy (IMRT) in people with Breast Cancer and Cancer, run by Youssef Zeidan at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Youssef Zeidan, M.D., Ph.D. ((561) 955-5966, youssef.zeidan@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of grade 3 or higher treatment-related adverse events (AEs) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06867484, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in