Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer.

June 26, 2015
NRG BR003
Breast Cancer
Amaryllis Gil, MD
Nancy Knowles Cancer Center, Elmhurst Memorial Hospital

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them 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.

Sponsor: NRG-Oncology

View more information about NRG-BR003 at ClinicalTrials.gov

  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
  • Primary tumor must be pT1-3, no T4 tumors including inflammatory breast cancer
  • Ipsilateral nodes must be pN0, pN1, pN2a, pN2b, pN3a, or pN3b
  • If pN0, tumor must be > 3.0 cm
  • No metastatic disease
  • No current or previous invasive breast cancer
  • No previous therapy with anthracyclines or taxanes for any malignancy
  • The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor (ER)- negative, and progesterone receptor (PgR)-negative 
  • The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy
  • For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS)
  • For patients who undergo mastectomy, the margins must be free of residual gross tumor
  • The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days
  • No conditions that would prohibit administration of corticosteroids
  • No chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)
  • This is a partial list of eligibility criteria. 

10 years

Accepting Participants
Interventional
III
Kathy Seymour, BSN
(331) 221-2168