Breast Cancer Clinical Trial
Official title:
A Phase 1/2 Study of XL147 (SAR245408) Administered in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen
Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in
combination with trastuzumab (Herceptin) and in combination with trastuzumab and paclitaxel.
After the MTD is established for each combination (Phase 2), subjects will be enrolled to
evaluate the preliminary efficacy and safety of these combinations in metastatic HER2
positive breast cancer. Both trastuzumab and paclitaxel are used in the treatment of
metastatic breast cancer (MBC), but patients can develop resistance.
The link between PI3K mutations and trastuzumab resistance has been seen in breast cancer
patients. This suggests that inhibitors of the PI3K/PTEN pathway may have the potential to
restore sensitivity to trastuzumab. Similarly, introduction of activated mutant forms of
PI3K has been shown to transform and confer paclitaxel resistance to immortalized breast
epithelial cells. XL147 is a potent and selective inhibitor of PI3K and inhibits
phosphorylation of multiple downstream components of PI3K/PTEN signaling. Therefore, XL147
may have utility in the treatment of trastuzumab resistant/refractory and HER2-positive MBC
when administered in combination with trastuzumab alone or with trastuzumab and paclitaxel.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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