Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in
      chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. It is not yet known whether
      giving cetuximab together with carboplatin is more effective than giving cetuximab alone in
      treating metastatic breast cancer.

      PURPOSE: This randomized phase II trial is studying cetuximab and carboplatin to see how well
      they work compared with cetuximab alone in treating women with estrogen receptor-negative
      (ER-), progesterone receptor-negative (PR-) metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the overall response rate in women with estrogen receptor-negative, progesterone
           receptor-negative, human epidermal growth factor receptor 2 (HER2)-nonoverexpressing
           metastatic breast cancer treated with cetuximab with vs without carboplatin.

      Secondary

        -  Compare the time to disease progression in patients treated with these regimens.

        -  Correlate downstream effects of epidermal growth factor receptor (EGFR) inhibitor on
           Mitogen-activated protein kinases (MAPK), Protein kinase B (AKT), monoclonal antibody
           Ki-67 (Ki67), and EGFR-dependent signaling, proliferation, and apoptosis with toxicity
           and response in patients with accessible tumors treated with these regimens.

        -  Determine the changes in biomarkers and gene expression in circulating tumor cells
           during treatment.

        -  Compare the overall survival rate in patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients receive cetuximab IV over 60-120 minutes once a week.

        -  Arm II: Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15.

      In both arms, treatment repeats every 28 days in the absence of disease progression or
      unacceptable toxicity. Patients not responding to treatment in arm I may cross over to arm
      II.

      Blood samples are collected periodically throughout study for correlative biomarker analysis
      by Immunohistochemistry (IHC) and gene expression analysis.

      After completion of study treatment, patients are followed every 4 months.
    

Intervention name(s): cetuximab; carboplatin
Intervention type(s): Biological; Drug
Intervention description(s): Given IV; Given IV
Other intervention name(s): Erbitux; Paraplatin
Intervention MeSH terms: Carboplatin; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IV breast cancer