New hope for breast cancer recurrence: repeat radiation may spare the breast
NCT ID NCT06362616
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study is for women aged 51 or older whose breast cancer has returned or who have a new cancer in the same breast. The goal is to see if giving a focused, short course of radiation before surgery is safe and effective enough to allow breast-conserving treatment instead of mastectomy. Researchers will monitor side effects and quality of life for three months after treatment.
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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 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Apr 2027
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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51 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: * Female patients ≥ 51 years * Ipsilateral breast cancer; recurrence or second primary * Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging) * Histologically proven estrogen receptor positive * HER2neu negative * In case of invasive adenocarcinoma: tumor size ≤ 3 cm. In case of DCIS alone: affected area ≤ 2.5 cm * Grade I or grade II (biopsy) * cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan) * Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision) * Interval since completion of local treatment of primary tumor \> 12 months * Previous radiotherapy (whole breast or partial) of the ipsilateral breast * Repeat breast conserving surgery feasible * World Health Organization (WHO) performance ≤ 2 * Written informed consent * The patient is legally competent Exclusion Criteria: * ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor * Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area * Distant metastases and/or synchronous contralateral invasive or in situ carcinoma * Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS) * ER negative subtype * Lymphovascular invasion in biopsy * Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy ≤ 2 months) * (Planned) oncoplastic surgery with major tissue displacement * Participation in another clinical trial that interferes with the locoregional treatment of this protocol. * It is expected that dosimetric constraints cannot be met, such as lung/heart constraints. * Patients with proven BRCA-mutations
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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
1 site. 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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The Netherlands Cancer Institute
RECRUITINGAmsterdam, 1066CX, Netherlands
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