Breast Cancer BR003

April 11, 2017

Sponsor: NRG Oncology

Number: BR003
Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III trials are new treatments that have worked well in a small number of patients with a this disease) studies how well Doxorubicin Hydrochloride and Cyclophosphamide followed by Paclitaxel with or without Carboplatin work in treating patients with triple-negative breast cancer (a triple negative breast cancer diagnosis means that the tumor is estrogen receptor-negative, progesterone receptor-negative and HER2-negative). Estrogen receptors and progesterone receptors are receptors that may be found in breast cancer cells.  Drugs used in chemotherapy, such as Doxorubicin Hydrochloride, Cyclophosphamide, Paclitaxel, and Carboplatin, work in different ways to stop the growth of tumor cells. They work either by killing the cells, stopping cells from dividing, or by stopping cells from spreading. It is not yet known whether Doxorubicin Hydrochloride and Cyclophosphamide is more effective when followed by Paclitaxel alone or Paclitaxel and Carboplatin in treating triple-negative breast cancer.

Who’s eligible: 

  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. ECOG status is used by your doctor in order to assess how your disease is progressing, assess how the disease effects of your daily living abilities, and determine appropriate treatment and prognosis.
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination (cancer in one breast that has grown into normal surrounding tissue). All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met:
    • By pathologic evaluation, primary tumor must be pT1-3 (stage).
    • By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b (amount of lymph nodes involved).
    • If pN0, tumor must be > 3.0 cm (N0=no lymph nodes involved). 
  • The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2) (an oncogene, a gene that has the potential to cause cancer)-negative.
  • The tumor must have been determined to be estrogen receptor (ER)-and progesterone receptor (PgR)-negative assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Estrogen receptors and progesterone receptors are receptors that may be found in breast cancer cells. The patient must have undergone either a mastectomy (the removal of the whole breast- total, skin-sparing, or nipple-sparing) or lumpectomy (surgery to remove cancer or other abnormal tissue from your breast).
  • This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, MidState Medical Center, and Hartford Hospital.

Cancer Clinical Research Office