Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction
This is a randomized, two-arm, un-blinded, non-inferiority trial comparing the impact of hypofractionated dosing (vs. standard dosing) of radiation on the 24 month breast reconstruction complication rate.
•Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular). In-situ disease alone is not allowed.
•Final AJCC Stage IIa – IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status). (Note: All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) will not be eligible to enroll.)
•No prior radiation therapy to the chest, neck or axilla.
•No prior history of ipsilateral breast cancer (invasive disease or DCIS). LCIS and benign breast disease is allowed.
•No history of prior or concurrent contralateral invasive breast cancer. Benign breast disease, LCIS or DCIS of contralateral breast is allowed.
•No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis.
•Negative inked histologic margins from mastectomy pathology (no invasive cells at margin).
•No significant post mastectomy complications requiring an unplanned re-operation or admission for IV antibiotics.
•Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements.
•Radiation oncologist is NOT planning to utilize a chest wall/scar boost.
•Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 8 months after radiation.
•For patients with diabetes, hemoglobin A1C test must have been performed less than or equal to 90 days prior to registration.
•No co-existing medical conditions with life expectancy < 5 years.
•No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
Alison Conlin, M.D.
The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.