Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab; Pertuzumab; Paclitaxel; Doxorubicin; Cyclophosphamide; Mastectomy; Radiation Therapy
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Trastuzumab; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research study is a Phase II clinical trial, which tests the safety and effectiveness of
      an investigational drug to learn whether the drug works in treating a specific cancer. In
      this study, paclitaxel and trastuzumab are being combined with pertuzumab which is
      "investigational" for the preoperative treatment of inflammatory breast cancer. Trastuzumab
      is given for a total of 12 months for the treatment of HER2 positive breast cancer. This
      study also adds pertuzumab to trastuzumab so that both drugs are given for a total of 12
      months; this combination is also "investigational".

      "Investigational" means that pertuzumab is being studied. It also means that although the FDA
      has approved pertuzumab for preoperative use to treat breast cancer, it has not been
      thoroughly studied in combination with paclitaxel and trastuzumab for preoperative treatment
      of inflammatory breast cancer. It has been FDA approved for specific use in advanced breast
      cancer that is HER2 positive.

      Pertuzumab is an antibody, which is a protein that attacks a foreign substance is the body.
      Pertuzumab blocks the function of the HER2 protein like trastuzumab does. However, pertuzumab
      binds to a different part of the HER2 receptor and stops cancer cells from growing. This drug
      has been used in the treatment of advanced breast cancer that is HER2 positive, and has been
      combined with trastuzumab and chemotherapy in those studies. Information from those other
      research studies suggests that pertuzumab may help to kill the cancer cells in the breast and
      enable you to undergo a mastectomy. The addition of pertuzumab may also help reduce the
      chance of cancer recurrence.

      In this research study, we are combining pertuzumab with paclitaxel and trastuzumab as
      preoperative therapy and will determine the response of the cancer remaining in the breast at
      the time of mastectomy. In addition, we are combining trastuzumab with pertuzumab for a total
      of 12 months and we are looking to see whether the combination reduces the chance that the
      cancer will return.

      Another goal of this research study is to determine whether we can develop a way to identify
      tumors that will respond well to this study treatment. We will do research tests on your
      tumor tissue before, during and after study treatment. These tests may help doctors
      understand how the study treatment may work to treat your type of breast cancer. In the
      future, these tests may help us find ways to help match patients with the drugs most likely
      to work against their specific tumors before treatment begins.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed invasive breast cancer

          -  HER2 positive breast cancer

          -  Clinical diagnosis of inflammatory breast cancer

          -  Without evidence of visceral or bone involvement with metastatic cancer on physical
             exam or any diagnostic study. Extensive nodal involvement is allowed

          -  Willingness to undergo a research biopsy of the affected breast

        Exclusion Criteria:

          -  Prior therapy for the treatment of breast cancer

          -  Receiving any other investigational or commercial agents or therapies

          -  Known brain metastases

          -  Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs
             resulting in dyspnea at rest

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to paclitaxel, trastuzumab, pertuzumab

          -  Uncontrolled intercurrent illness

          -  Pregnant or breastfeeding

          -  History of a different malignancy except for the following circumstances: disease-free
             for at least 5 years and at low risk of recurrence, or cervical cancer in situ or
             basal or squamous cell carcinoma of the skin

          -  HIV positive on combination anti-retroviral therapy