Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa
Status:
Active, not recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
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.