Post Mastectomy Radiation w/Breast Reconstruction (A221505)

For a patient to be eligible for participation in this study, all of the following criteria must apply.

• 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
• Patients will be staged according to the TNM staging system; pathologic stage T0N1-2a, T1N1a-2a, T2N1-2a, 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
  * 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 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 in the ipsilateral breast 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 18 months after radiation
• If a tissue expander is utilized it needs to be a fluid filled expander, NO air expander (unless completely deflated) during radiation therapy
• 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

To learn more, visit ClinicalTrials.Gov

Study Type

Phase III

Principal Investigator(s)

Amarinthia Curtis, MD

Sponsor(s)

Alliance for Clinical Trials in Oncology