About this trial
To compare the outcomes of and responses to 2 different radiation therapy schedules (the standard radiation amount and number of doses versus less radiation and fewer doses) that are being given before having breast cancer surgery (cancer removal and reconstruction).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Histologic diagnosis of invasive breast cancer (cytologic or histologic confirmation of nodal metastasis is sufficient to establish this eligibility criteria).
Clinical and/or pathologic stage T3-T4c OR N1-N3; for the IBC pilot cohort only, the stage requirement is T4d, any N, M1
Mastectomy is the planned oncologic surgery but has not yet been performed at the time of protocol enrollment
Disqualifiers
Patients undergoing treatment for recurrent breast cancer in the index breast or lymph nodes.
History of therapeutic irradiation to the breast, lower neck, mediastinum or other area(s) that will overlap with the affected breast.
Presence of active scleroderma
Patients who are pregnant.
Trial design
Single group
Treatments tested in this trial
Group 1 (preoperative radiation hypofractionated)
Radiationradiation schedules/regimens before your scheduled breast surgery
Group 2 (preoperative radiation conventionally fractionated)
Other interventionradiation schedules/regimens before your scheduled breast surgery
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
Artidis
Collaborator