Breast Cancer Clinical Trial
Official title:
A Phase 1/2 Dose-Escalation Study of XL147 (SAR245408) or XL765 (SAR245409) in Combination With Letrozole in Subjects With Hormone Receptor-Positive and HER2-Negative Breast Cancer Refractory to a Nonsteroidal Aromatase Inhibitor
Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in
combination with letrozole (Femara) and of XL765 when given in combination with letrozole.
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 subjects with breast
cancer refractory to a non-steroidal aromatase inhibitor that is ER+/PGR+ and HER2-.
Letrozole is used in the treatment of different types of breast cancer, but patients can
develop resistance.
Upregulation of PI3K activity is one of the most common characteristics of human cancer
cells, including breast tumor cells. Activation of PI3K results in stimulation of AKT and
mTOR kinases, resulting in the promotion of tumor cell proliferation and survival.
Preclinical and retrospective clinical data suggest that aberrant activation of the PI3K
pathway may play a role in aromatase inhibitor resistance in patients with ER+, HER2- breast
cancer. XL147 is a potent inhibitor of PI3K, and XL765 is a potent dual inhibitor of PI3K
and mTOR; therefore either of these compounds in combination with letrozole warrants
clinical investigation.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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