Hypofractionated LocoRegional Radiotherapy in Breast Cancer (NCT04228991) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Hypofractionated LocoRegional Radiotherapy in Breast Cancer
Canada588 participantsStarted 2021-02-10
Plain-language summary
The primary objective of this study is to determine if hypofractionated RT delivered over 1 week to the breast or chest wall and regional nodes (26Gy in 5 daily fractions) following BCS or mastectomy, is non-inferior to conventional fractionation to the breast or chest wall and regional nodes delivered over 3 weeks (40Gy in 15 daily fractions) in patients with node-positive breast cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed invasive carcinoma of the breast.
✓. Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.\* Note: \*Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible.
✓. Candidate for locoregional radiotherapy: breast cancer stage after definitive surgery:
✓. No evidence of metastatic disease.
Exclusion criteria
✕. Age \< 18 years.
✕. Clinical stages T4 and/or N3.
✕. Clinical lymphedema in the ipsilateral arm or breast/chest wall.
✕. Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with previous ipsilateral DCIS or LCIS not treated with radiation are eligible.)
✕. Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.)
✕. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.
✕. Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.)