5-Day radiation blitz after mastectomy: game changer or risk?
NCT ID NCT04648904
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving radiation over just 5 days in a row, instead of the usual longer schedule, is safe and works well for breast cancer patients who have had a mastectomy and breast reconstruction. The goal is to prevent cancer from coming back in the chest or nearby lymph nodes. The study involves 71 adults aged 30 and older with stage IIa to IIIa invasive breast cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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71 people
The number who actually took part.
- Started
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Nov 2020
- 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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30 years and older
- Sex
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Anyone
- 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 or male patients with invasive breast cancer who have had mastectomy and have a chest wall reconstruction in progress or completed. * Age ≥ 30 years * Final AJCC Stage IIa - IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status). Pathological stage for all patients not receiving neoadjuvant chemotherapy. Higher of the clinical or pathological T and N stage, if receiving neoadjuvant chemotherapy. T3N0 patients, either clinically by imaging before neoadjuvant chemotherapy, or by pathological stage at the time of surgery, are eligible. Exceptions to these criteria (e.g. for T4 or N3 patients) are possible after discussion with PI. * Histologically negative tumor margin. * ECOG Performance Status of 0 or 1 Exclusion Criteria: * Patients with distant metastasis. * Patients who are pregnant or breastfeeding. * Prior radiation therapy to the ipsilateral or contralateral breast or thorax. * All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) will not be eligible to enroll. * 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. * Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. However endocrine therapies (tamoxifen or aromatase inhibitors), anti-HER2 therapy and bisphosphonates are permitted without restriction even during protocol treatment. Standard-of-care maintenance treatments such as pembrolizumab and capecitabine are permitted during protocol treatment. All of these treatments are delivered routinely as SOC during conventional radiotherapy. * Unwilling or unable to participate in all required study evaluations and procedures. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).
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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 Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can sound waves replace the scalpel for breast cancer?
- Can fewer, stronger radiation doses match standard treatment after mastectomy?
- Can radiation before or after breast reconstruction improve outcomes?
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- Personalized chemo: could tumor DNA hold the key to better breast cancer treatment?