Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery

October 17, 2014
B-51
Breast Cancer
Vasudah Lingareddy, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.

Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)

http://clinicaltrials.gov/ct2/show/NCT02003209?term=02003209&rank=1

Inclusion Criteria:
  • T1-3, N1 breast cancer at diagnosis and before neoadjuvant therapy
  • Completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
  • Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy unless medically contraindicated
  • Patients who have undergone either a total mastectomy or a lumpectomy are eligible
  • The interval between the last surgery for breast cancer and randomization must be no more than 56 days; also, the interval between the last adjuvant chemotherapy treatment, if any, and randomization must be no more than 56 days

Exclusion Criteria:
  • Definitive clinical or radiologic evidence of metastatic disease
  • Previous or current invasive breast cancer or DCIS in the opposite breast
  • Any prior history of same breast invasive breast cancer or DCIS treated with radiation therapy
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
  • Any radiation therapy for the currently diagnosed breast cancer prior to randomization
  • Prior breast or thoracic radiation therapy (RT) for any condition

10-12 years

Accepting Participants
Interventional
III
Kathy Seymour, BSN
630-646-6075
630-646-6110
630-646-6072