Could a Two-Week radiation blast be enough for early breast cancer?
NCT ID NCT01203839
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a shorter radiation treatment (partial breast irradiation) for women with early-stage breast cancer or a pre-cancer called DCIS. Instead of treating the whole breast for 5-7 weeks, radiation is given only to the area where the tumor was removed, for just 2 weeks. The goal is to see if this approach is safe, has fewer side effects, and keeps the cancer from coming back in the same breast.
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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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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2010
- Expected to finish
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Sep 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: * Female * Age ≥ 18 years * Unicentric Stage I (T1N0M0) invasive ductal breast cancer or Grade 1 or II DCIS measuring \<2 cm on pathology and/or mammogram that is histologically confirmed at MSKCC * Histologically negative tumor margin 2 mm or more from any inked edges or no tumor in a re-excision specimen or final shaved specimen * ECOG Performance Status of 0 or 1 * Granulocytes ≥1,500/μl and platelet count must be ≥100,000/μl at the beginning of therapy for patients treated with adjuvant chemotherapy * Women \>70 years or older with T1 invasive ductal carcinoma who are estrogen-receptor positive (ER+) with clinically negative axillary nodes and do not undergo surgical lymph node evaluation are eligible if patient will take hormonal therapy. * Patients with T1N0(i+) tumors on sentinel lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible. * Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery. Exclusion Criteria: * Patients with distant metastasis. * Patients who are pregnant or breastfeeding. * Patients with diffuse (\>1 quadrant or \>5 cm) suspicious microcalcifications. * Prior radiation therapy to the ipsilateral or contralateral breast or thorax. * Histological evidence of lymphovascular invasion (LVI). Cases termed focally suspicious for LVI but where no definitive LVI is found are eligible. * Histologic evidence of EIC, defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion. * Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. However, in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study. It would be an extremely rare/unlikely scenario for patients to be discovered BRCA positive after the completion of PBI, as all patients with risk factors for BRCA mutations (positive family history, Ashkenazi Jewish descent, ER-/PR-/her2-neu negative receptor status) are usually tested prior to radiation. Should such a situation exist, these patients will not receive additional RT and the patient will be replaced in the trial. * History of cosmetic or reconstructive breast surgery. * Psychiatric illness that would prevent the patient from giving informed consent. * Patients for whom the delivery of PBI is not feasible * Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. * Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their physicians to be at \<5% risk of relapse within 3 years. * Patients who are already enrolled in or planning to enroll in other adjuvant systemic therapy protocols for both non-invasive or invasive 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.
Contacts and locations
Locations
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Memorial Sloan Kettering Bergen (Follow-up Only)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk (Follow-up Only)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Follow-up Only)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Follow-up Only)
Harrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (Follow-up Only)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering at Mercy Medical Center (Follow-up Only)
Rockville Centre, New York, United States
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Other studies related to the condition(s) this trial covers.
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