Accelerated Intensity Modulated Radiation Therapy (AIMRT) to the Breast After Segmental Mastectomy
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
The primary purpose of this study is to determine the feasibility and tolerability of a regimen of accelerated (hypofractionated) Intensity Modulated Radiation Therapy (AIMRT) to the whole breast as part of breast preservation. In addition, the investigators want to prospectively collect blood specimens to: assess TGF-β polymorphisms to identify potential carriers at higher risk for post-treatment fibrosis; generate a blood specimen repository for future studies of other relevant polymorphisms. The study investigators also want to prospectively follow each treated woman yearly to assess long-term radiation sequelae of the current regimen by using the LENT/SOMA scores.
Key facts
- Study ID
- NCT02606708
- Run by
- NYU Langone Health
- People needed
- 314
- Starts
- 2005-02-20
- Expected to finish
- 2017-06-02
- Last updated by the study team
- 2020-08-14
Who can join
Age: 19 and older, up to 90. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pre- or post-menopausal women with Stage I and II breast cancer
- Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
- Status post segmental mastectomy. and after sentinel node biopsy and/or axillary node dissection
- At least 2 weeks from last chemotherapy
- Tumors < 5 mm do not require nodal assessment
You may not qualify if…
- Previous radiation therapy to the ipsilateral breast.
- More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation.
- Active connective tissue disorders, such as lupus or scleroderma.
- Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free > 5 years.
- Pregnant or lactating women.
Where it is running
- NYU Langone Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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