"Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma"
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
The objective of the study are as below: 1) Compare the effect of short course versus long course post mastectomy radiation therapy on highly relevant patient reported outcomes and outcomes prioritized by individual trial participation.2) Compare the clinical outcomes for patient receiving short term and long term radiation.
Inclusion Criteria1.Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor2.Has been treated with mastectomy3.Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy4.Is a candidate for unilateral post-mastectomy radiation therapy as per National Comprehensive Cancer Network (NCCN) guidelines (post-mastectomy radiation therapy is indicated for most patients with positive lymph nodes at time of surgery and infrequently for selected node-negative patients)5.Use of bolus is permitted, but not required6.Age equal to 183Exclusion Criteria1.T4 cancer2.Recurrent breast cancer or history of prior breast radiation therapy3.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or mental health illness that the consenting investigator feels would affect patient’s ability to participate in this study4.Pregnant or nursing5.History of a different malignancy except for the following circumstances:6.Disease-free for at least five years and deemed by the investigator to be at low risk for recurrence of that malignancy ( less than 5 %).
400 patients will be randomized 1:1 into either Arm 1 (short-course PMRT) or Arm 2 (long- course PMRT).Randomization will be stratified by treatment center and age of the patient ( less than 45 vs. equal to 45).
08/08/2020 05:02 AM