Re‑irradiating the breast after a second lumpectomy
Official title: Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)
Run by Baptist Health South Florida · NCT06867484 · Data updated 2026-11-12
This trial will test whether targeted re‑irradiation (IMRT) after a second lumpectomy is safe for people with ER+ / HER2‑ breast cancer who previously received breast radiation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | Women only |
| Enrollment | 114 (estimated) |
| Sponsor | Baptist Health South Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Boca Raton, Florida and 1 other locations) |
| Status | Recruiting |
| Started | October 27, 2025 |
| Main results expected | May 2028 |
| Study ends | May 2033 |
| Registry record updated | November 13, 2025 |
| Trial ID | NCT06867484 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people age 40 or older with ER+ / HER2‑ unifocal ipsilateral recurrence <3 cm, negative margins, node‑negative (N0), ECOG ≤2, oncotype scores in the low/ultra‑low range (postmenopausal <26; premenopausal <16), at least 18 months since prior breast radiation, PTV:WB <1/2, and life expectancy >12 months.
✕Probably not a fit
Patients with multicentric or >3 cm recurrences, positive lymph nodes, very recent prior radiation (<18 months), unknown or excessive prior cumulative radiation dose (>68 Gy EQD2), HER2+ or ER‑ disease, pregnancy, or poor performance status are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial uses intensity‑modulated radiation therapy (IMRT) to deliver re‑irradiation to the whole breast after a second ipsilateral lumpectomy, focusing on safety and adverse effects. Eligible patients are generally age ≥40 with ER+/HER2‑, unifocal ipsilateral recurrence <3 cm with negative margins and no nodal disease, who had prior breast radiation at least 18 months earlier and meet specified cumulative dose limits. Key technical limits include a planning target volume to whole breast ratio under 1/2 and an upper cumulative prior dose of about 68 Gy (EQD2) when records are available. The trial is conducted at two Baptist Health centers in Florida and will monitor side effects and local control following re‑irradiation.
Why it matters
Potential benefit: If successful, this approach could allow some patients to keep their breast after a second lumpectomy while controlling the recurrence with acceptable side effects.
How similar studies have gone: Small series and nonrandomized reports have shown breast re‑irradiation can be feasible and achieve local control with acceptable toxicity in selected patients, but high‑quality randomized data are limited.
Who can join: the full rules
Show full inclusion / exclusion 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: 1. Has not undergone a hysterectomy or bilateral oophorectomy; or 2. 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.
Where it's running
-
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, United States Recruiting -
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Youssef Zeidan, M.D., Ph.D. — Lynn Cancer Institute at Baptist Health, Inc.
- Study coordinator: Youssef Zeidan, M.D., Ph.D.
- Email: youssef.zeidan@baptisthealth.net
- Phone: (561) 955-5966
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.