A Single Arm, Neoadjuvant, Phae II Trial of Pertuzumab and Trastuzumab Administered Concomitantly with Weekly Paclitaxel and FEC for Clinical Stage I-III HER2-Positive Breast Cancer
Trial Purpose and Description
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. Preoperative paclitaxel and trastuzumab are used as standard preoperative treatment for HER2 positive inflammatory breast cancer. In this study, paclitaxel andtrastuzumab are being combined with pertuzumab, which is investigational. 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.
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.
- 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
- Yale University
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