HER2-positive Breast Cancer Clinical Trial
Official title:
A Phase I Clinical Trial of Ganetespib (Heat Shock Protein 90 Inhibitor) in Combination With Paclitaxel, Trastuzumab and Pertuzumab in Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of ganetespib when given with paclitaxel, trastuzumab and pertuzumab in treating patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer (MBC).
This phase I trial studies the side effects and best dose of ganetespib when given with
paclitaxel, trastuzumab, pertuzumab in treating patients with human epidermal growth factor
receptor 2 positive (HER2+) breast cancer that has spread to other places in the body and
usually cannot be cured or controlled with treatment (advanced) or has returned after a
period of improvement (metastatic). HER2+ describes cancer cells that have too much of a
protein called HER2 on their surface. In normal cells, HER2 helps to control cell growth.
When it is made in larger than normal amounts by cancer cells, the cells may grow more
quickly and be more likely to spread to other parts of the body.
Ganetespib may stop the growth of tumor cells by blocking some of the proteins needed for
cell growth. Drugs used in chemotherapy, such as paclitaxel, 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. Monoclonal antibodies, such as trastuzumab and pertuzumab, bind
to HER2+ cancer cells and may kill them. Giving ganetespib with paclitaxel, trastuzumab, and
pertuzumab may be a better treatment for patients with HER2+ breast cancer.
This phase I study has two parts. During the first part of this study, patients with HER2+
MBC receive trastuzumab in combination with ganetespib and paclitaxel to evaluate the safety,
toxicity and maximum tolerated dose (MTD) of this triplet regimen. There are dose escalations
for ganetespib. Paclitaxel and trastuzumab are administered at standard doses without
escalation. Part 1 is ongoing.
During the second part of this study, pertuzumab at standard dose will be added to the
triplet regimen of ganetespib, paclitaxel and trastuzumab, using the MTD of ganetespib
determined in part one. The MTD of ganetespib and the safety of the four-drug regimen will be
evaluated. The MTD for ganetespib in combination with paclitaxel and trastuzumab is 150
mg/m2.
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