Last updated on March 2019

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lobular carcinoma | Stage IIA Breast Cancer | Invasive Ductal Breast Carcinoma | Stage II Breast Cancer | Medullary Breast Carcinoma | Stage IIIA Breast Cancer | Tubular Breast Carcinoma | Invasive Breast Carcinoma | Stage IIB Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

  • 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 American Joint Committee on Cancer (AJCC) stage IIa - IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status); pathological stage for all patients not receiving neoadjuvant chemotherapy; higher of the clinical or pathological T and N stage, if receiving neoadjuvant chemotherapy; patients with pathological N0 at the time of mastectomy are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to induction chemotherapy
    • No prior radiation therapy to the chest, neck or axilla
    • No prior history of ipsilateral breast cancer (invasive disease or ductal breast carcinoma in situ [DCIS]); lobular carcinoma in situ (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 intravenous (IV) antibiotics; re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable
    • Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended)
    • 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 =< 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
    • Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =< 7 days prior to registration; a female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
    • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
    • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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