Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer

August 01, 2014
B-52
Breast Cancer
Joseph Kash, 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

  • The tumor must have been determined to be HER2-postive and estrogen receptor (ER) and/or progesterone (PgR) positive 
  • Excisional biopsy or lumpectomy must not have been performed prior to randomization
  • No definitive clinical or radiologic evidence of metastatic disease
  • No prior treatment including radiation therapy (RT), chemotherapy, targeted therapy, or endocrine therapy for the currently diagnosed breast cancer prior to randomization
  • No previous endocrine therapy such as raloxifene or tamoxifen (or other selective estrogen receptor modulator [SERM]) or an aromatase inhibitor or previous therapy with anthracycline, taxanes, carboplatin, trastuzumab, or other HER2 targeted therapies
  • No cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens, uncontrolled hypertension, active hepatitis, uncontrolled diabetes, or nervous system disorder

5-6 years

Accepting Participants
Interventional
III
Kathy Seymour, BSN
630-646-6050
630-646-6110
630-646-6075