Could repeat radiation save breasts after cancer returns?
NCT ID NCT04371913
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether women who had breast cancer come back after earlier lumpectomy and radiation can avoid a mastectomy by getting a second round of targeted radiation. About 120 women with small, isolated recurrences will receive partial or whole breast radiation depending on their prior treatment. The main goal is to see if this approach is safe and does not cause severe side effects.
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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 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Dec 2035
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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19 to 90 years
- 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: * Isolated ipsilateral unifocal breast lesions * Limited size (\< 2-3 cm) without evidence of skin involvement * Histologically proven invasive breast carcinoma or carcinoma in situ * Negative histologic margins of resection * Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension * No synchronous distant metastases * Age ≥ 18 years * ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence * Previous WBI or IORT, brachytherapy or external beam partial breast treatment * Technical feasibility * Every kind of systemic therapy is allowed * Informed consent for clinical and research purposes signed Exclusion Criteria: * Regional recurrences (axillary, supraclavicular) * Positive histologic margins at resection * Metastatic disease * Poor cosmesis from previous surgery and RT * Extensive Intraductal Component
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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
3 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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New York Presbyterian Brooklyn Methodist Hospital
RECRUITINGBrooklyn, New York, 10065, United States
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New York Presbyterian Hospital - Queens
RECRUITINGNew York, New York, 10065, United States
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Weill Cornell Medicine
RECRUITINGNew York, New York, 10065, United States
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Other studies related to the condition(s) this trial covers.
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