New radiation approach aims to cut treatment time and side effects for breast cancer
NCT ID NCT03077841
First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This study tests a shorter, more focused radiation treatment (hypofractionated partial breast irradiation) for women with early-stage breast cancer. The goal is to see if targeting only the tumor site can reduce side effects and improve cosmetic outcomes compared to standard whole-breast radiation. About 928 participants who had breast-conserving surgery are being studied, but the trial is currently suspended.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hypofractionated partial breast irradiation (radiation therapy)
- What this could lead to
- If successful, this could offer a shorter, more convenient radiation treatment with fewer side effects for women with early-stage breast cancer.
- What could go wrong
- The trial is currently suspended, and it is a phase II/III study, so results are not yet confirmed. The approach may not be as effective or safe as standard whole-breast radiation.
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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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 928 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2017
- Expected to finish
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Nov 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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50 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: * Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ * Pathologic T stage of Tis, T1, or T2 with total size of tumor =\< 3 cm (this size criteria applies to both pure DCIS and invasive tumors) * For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS * Treatment with breast conserving surgery * Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed * Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded * For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor) * If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer * Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy * Final criteria for eligibility established after simulation: The tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation Exclusion Criteria: * Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature * Any evidence of nodal positivity beyond pathologic stage of pN0(i+) * Systemic chemotherapy prior to final breast conserving surgery * Patient is pregnant or nursing * History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast * History of prior invasive or in situ cancer in either breast * Current diagnosis of bilateral breast cancer * History of lupus or scleroderma
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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
15 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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Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
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Community Cancer Center East
Indianapolis, Indiana, 46219, United States
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Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
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Covenant Medical Center Harrison
Saginaw, Michigan, 48602, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043, United States
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MD Anderson League City
League City, Texas, 77573, United States
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MD Anderson West Houston
Houston, Texas, 77079, United States
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MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
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MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
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OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
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Piedmont Hospital
Atlanta, Georgia, 30309, United States
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Presbyterian Hospital
Albuquerque, New Mexico, 87106, United States
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Saint Luke's Baptist Health System
San Antonio, Texas, 78229, United States
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Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- One shot of radiation: can a single dose replace weeks of breast cancer treatment?
- Could skipping a lymph node check spare women from unneeded surgery?
- Could shedding pounds after breast cancer keep the disease away?
- Can a Tumor-Blood-Vessel blocker boost hormone therapy for advanced breast cancer?
- 3D imaging could help surgeons remove all breast cancer in one go