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Re-irradiation for Breast Cancer After Lumpectomy

This study is looking at the safety and potential side effects of a radiation treatment called Intensity Modulated Radiation Therapy (IMRT) for breast cancer. This treatment is given to women who have already had radiation therapy before surgery and are now having it again after a second lumpectomy (breast surgery to remove a tumor). You may be able to join if you are a woman aged 40 or older, have ER+HER2- breast cancer, and meet certain other criteria, including specific Oncotype scores and having at least 18 months since your last breast radiation. The main goal is to see how many participants experience serious side effects within one year. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 114 women. It is testing a specific radiation treatment.
What's involved
You would receive 15 consecutive weekday sessions of Intensity Modulated Radiation Therapy (IMRT) to the partial breast. You would also need to comply with all study procedures and be available for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
Your treatment-related side effects will be measured for one year after the treatment.

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NCT06867484

Breast Re-irradiation After Second Ipsilateral Lumpectomy

Recruiting
NAAges 40+InterventionalTreatment
Youssef Zeidan
~114 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Intensity modulated radiation therapy (IMRT)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of grade 3 or higher treatment-related adverse events (AEs)
Measured over 1 year

Conditions

Breast Cancer
Cancer
Cancer of the Breast
HER2-negative Breast Cancer
ER+ Breast Cancer
Estrogen-receptor-positive Breast Cancer

Explore related trials

Breast CarcinomaOncotype

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Youssef Zeidan, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Lynn Cancer Institute at Baptist Health, Inc.

Who to contact

Youssef Zeidan, M.D., Ph.D.
[email protected]
(561) 955-5966
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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • 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.