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Protocol No. A221505

Principal Investigator Anderson, Bethany

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction

Objective This study is being done to see if we can determine whether a short-course radiation therapy option (3 to 4 weeks) after mastectomy is as safe and effective in the setting of breast reconstruction as the usual 5 to 6 week treatment course. Short-course radiation therapy is also called hypofractionated radiation. This study will also examine whether a shorter course of radiation therapy will lower treatment costs and improve patient satisfaction.

Treatment
  • Group 1 will get the usual 5 to 6 weeks radiation therapy used for this type of cancer.
  • Group 2 will get a shortened course with 3 to 4 weeks radiation therapy for this type of cancer
  • Breast reconstruction may happen before or after radiation as predetermined by your surgeon.

  • Description
  • Randomized trial testing the safety and patient experience of short course radiation after mastectomy and breast reconstruction for breast cancer

  • Key Eligibility
  • 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).
  • No prior radiation therapy to the chest, neck or axilla
  • No prior history of ipsilateral breast cancer (invasive disease or DCIS).
  • No history of prior or concurrent contralateral invasive breast cancer
  • No active collagen vascular diseases
  • 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
  • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
  • ECOG (Zubrod) Performance Status 0-1, Patient ≥ 18 years of age

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Johnson Creek, UW Cancer Center; UW Hospital and Clinics