Can a second round of radiation save breasts after cancer returns?
NCT ID NCT06867484
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving radiation again after a second lumpectomy is safe for women with a common type of breast cancer (ER+HER2-). About 114 women who had radiation before and whose cancer came back at least 18 months later will receive targeted radiation over 3 weeks. The main goal is to see how many experience severe side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intensity modulated radiation therapy (IMRT)
- What this could lead to
- If successful, this could offer a safe option for women with breast cancer recurrence to receive radiation again after a second lumpectomy, potentially avoiding mastectomy.
- What could go wrong
- This is an early safety trial with only 114 participants, so results may not apply to everyone. Repeat radiation carries risks of side effects like skin damage or fibrosis, and it is not yet known if it effectively prevents cancer from coming back.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lynn Cancer Institute at Baptist Health, Inc.
RECRUITINGBoca Raton, Florida, 33486, United States
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Miami Cancer Institute at Baptist Health, Inc.
RECRUITINGMiami, Florida, 33176, United States
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