One-Week radiation blasts recurrent breast cancer, spares healthy tissue
NCT ID NCT05592938
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tests whether a 1-week course of partial breast radiation is safe and effective for women who have had a breast cancer recurrence after prior whole-breast radiation. Participants will receive targeted radiation after breast-conserving surgery to remove the new tumor. The goal is to avoid mastectomy while keeping side effects low.
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 171 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jun 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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18 to 99 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: * Age \> 18 years * In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma) * Tumour \<3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components * \>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted) * Clinically node negative * Negative margins (no tumour on ink) * Recovered from surgery with the incision completely healed and no signs of infection Exclusion Criteria: * Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible) * Tumour histology limited to lobular carcinoma only * T4 disease * Node positive or distant metastatic disease * Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment * Currently pregnant or lactating * Presence of an ipsilateral breast implant or pacemaker * Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy * Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips). * Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol * Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0 * Current or prior diagnosis of bilateral breast cancer
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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
19 sites in 10 countries. 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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A.C.Camargo Cancer Center
RECRUITINGSão Paulo, São Paulo, 105401, Brazil
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AOU Careggi - Florence University Hospital
RECRUITINGFlorence, Italy
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CHU de Québec-Université Laval
RECRUITINGMontreal, Quebec, G1G 5X1, Canada
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Centre hospitalier de l'Université de Montréal
RECRUITINGMontreal, Quebec, H2X 3E4, Canada
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Clinica IRAM
RECRUITINGVitacura, Santiago Metropolitan, 7630370, Chile
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Columbia University Medical Center
RECRUITINGNew York, New York, 10032, United States
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Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal
RECRUITINGMontreal, Quebec, H1T 2M4, Canada
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King Hussein Cancer Centre
RECRUITINGAmman, Jordan, Jordan
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Lakeridge Health
RECRUITINGOshawa, Ontario, L1G 2B9, Canada
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London Health Science Centre - Verspeeten Family Cancer Centre
RECRUITINGLondon, Ontario, N6A 5W9, Canada
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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Odette Cancer Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, Victoria, 3000, Australia
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Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G2C4, Canada
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Royal Victoria Regional Health Centre
RECRUITINGBarrie, Ontario, L4M 6M2, Canada
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Tel-Aviv Sourasky Medical Centre
RECRUITINGTel Aviv, Israel
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The Aga Khan University
RECRUITINGNairobi, Kenya
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Universitiy Malaya Medical Centre
RECRUITINGKuala Lumpur, Malaysia
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Virgina Community University Massey Comprehensive Cancer Center
RECRUITINGRichmond, Virginia, 23298-0037, United States
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