Breast Re-irradiation After Second Ipsilateral Lumpectomy

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Cancer, Cancer of the Breast, HER2-negative Breast Cancer, ER+ Breast Cancer, Estrogen-receptor-positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT06867484

Run by

Youssef Zeidan

People needed

114

Starts

2025-10-27

Expected to finish

2033-05-01

Last updated by the study team

2025-11-13

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Lynn Cancer Institute at Baptist Health, Inc. — Boca Raton, Florida, United States (enrolling)
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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