Can Pre-Surgery radiation improve breast cancer treatment?
NCT ID NCT07178665
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a short course of radiation to part of the breast before surgery is safe and practical for women with early-stage breast cancer. About 98 women over age 50 with small, hormone-sensitive tumors will receive radiation, then have surgery. Researchers will check for wound healing problems, cosmetic results, and how the tumor responds to radiation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 98 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jun 2028
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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50 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: Breast cancer patients with biopsy-proven invasive ductal cancer or DCIS Tumor size ≤ 2cm clinically and radiographically Estrogen-receptor positive (ER+) on biopsy Grade 1 or 2 on biopsy Clinically and radiographically node-negative disease No indication of metastatic disease Age \>50 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Negative serum pregnancy test if applicable Willingness to participate in the clinical trial and adhere to the study protocol Ability to understand and consent to the study Exclusion Criteria: Indication for neoadjuvant chemotherapy or hormone therapy Tumor size \>2cm clinically or radiographically ER- on biopsy G3 invasive cancer or DCIS on biopsy Lobular histology Multicentric/multifocal tumor BRCA+ gene mutation Prior ipsilateral breast or thoracic RT Contraindication for baseline MRI Contraindication for surgery Distant metastatic disease Other synchronous cancer (besides bilateral breast) Contraindication to Radiation therapy (presence of scleroderma or other collagen vascular disease) Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
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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
10 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039, United States
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Jack and Sheryl Morris Cancer Center
New Brunswick, New Jersey, 08901, United States
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RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755, United States
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RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerset, New Jersey, 08873, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, 08690, United States
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RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, 07109, United States
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RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
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RWJBarnabas Health Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
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Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202, United States
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Other studies related to the condition(s) this trial covers.
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- Can breast radiation be cut from three weeks to one?
- Can a clotting drug cut mastectomy wound drainage?