Shorter radiation course may spare breast cancer patients side effects
NCT ID NCT01266642
First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This study tests whether a shorter course of higher-dose radiation (hypofractionated) is as good as or better than standard radiation for early-stage breast cancer. About 300 women with ductal carcinoma in situ or early invasive breast cancer are participating. The main goal is to see if the shorter schedule leads to fewer cosmetic side effects while still controlling the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy
- What this could lead to
- If successful, this could offer a more convenient and less side-effect-prone radiation schedule for early breast cancer patients.
- What could go wrong
- This is a phase 2 trial with 301 participants, so results are preliminary. The shorter schedule may not be as effective or could have unforeseen long-term effects.
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
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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301 people
The number who actually took part.
- Started
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Feb 2011
- Expected to finish
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Nov 2040
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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40 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 confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with ductal carcinoma in situ \[DCIS\] only); (upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy; for such patients, the criteria for pathologic stage shall be applied to the initial clinical stage) * Treatment with breast conserving surgery * Final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin; if the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a re-excision is strongly encouraged; lobular carcinoma in situ at the final surgical margin will be disregarded * Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences. * Female sex. * Attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level I/II axilla with high tangents is allowed) * If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed 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 concurrent cytotoxic chemotherapy Exclusion Criteria: * Pathologic or clinical evidence for a stage T3 or T4 breast cancer * Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes * Clinical or pathologic evidence for distant metastases * Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast * Current diagnosis of bilateral breast cancer * History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast * Patients not fluent in English or Spanish (The BCTOS will be available in these two languages) * Patient is pregnant
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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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Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, 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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UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
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