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
Alexander Hantel, MD

Naperville, Plainfield

This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive, operable or locally advanced breast cancer. Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced 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
630-646-6050
630-646-6110
630-646-6075