One-Time radiation boost during breast surgery shows promise in Early-Stage cancer trial
NCT ID NCT02927912
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a single dose of radiation directly to the tumor site during breast-conserving surgery (lumpectomy) and before reconstruction is safe and effective for women with early-stage breast cancer. About 108 participants with stage I-II breast cancer will receive this targeted radiation boost. The goal is to kill remaining tumor cells while potentially improving cosmetic results and reducing the need for additional treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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108 people
The number who actually took part.
- Started
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Oct 2017
- Expected to finish
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Nov 2026
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 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: * Pathologically proven diagnosis of breast cancer * Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer * Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician * Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup * History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry * Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis * Absolute neutrophil count \> 1800 cells/cubic mm * Platelets \>= 75,000 cells/cubic mm * Hemoglobin \>= 8 g/dL * Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry * Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy * Patients must provide study specific informed consent prior to study entry Exclusion Criteria: * Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer * Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry * Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ \[LCIS\] is eligible) * Two or more cancers not resectable through a single lumpectomy incision * Bilateral breast cancer * Ductal breast carcinoma in situ (DCIS) only * Non-epithelial breast malignancies such as sarcoma/lymphoma * Male breast cancer * Paget's disease of the nipple * Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields * Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception * Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash * Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
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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.
Contacts and locations
Locations
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Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
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Centre Hospitalier de I'Universite de Montreal
Québec, Montreal, H2X0C1, Canada
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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University Hospitals
Cleveland, Ohio, 44106, United States
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University of North Carolina
Chapel Hill, North Carolina, 27599, United States
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Other studies related to the condition(s) this trial covers.
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