A Phase 1/2 Study of XL147 Administered in Combination with Trastuzumab or Paclitaxel and Trastuzumab in Subjects with Metastatic Breast Cancer who have Progressed on a Previous Trastuzumab- Based Regimen

Femme Homme

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Extrait

The primary objectives are: • To evaluate the safety and tolerability of XL147 in combination with trastuzumab and in combination with trastuzumab and paclitaxel. • To determine the maximum tolerated dose (MTD) of XL147 when administered in combination with trastuzumab and in combination with trastuzumab and paclitaxel (Phase 1). • To estimate the efficacy endpoint of objective tumor response rate (ORR) in the study population and in subpopulations based on the presence or absence of tumor PI3K pathway alterations (ie, molecular alterations that directly affect the PI3K pathway: PIK3CA mutation/amplification and/or PTEN deficiency) (Phase 2).

Critère d'inclusion

Subjects with Metastatic Breast Cancer who have Progressed on a Previous Trastuzumab-Based Regimen

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A Phase 1/2 Study of XL147 Administered in Combination with Trastuzumab or Paclitaxel and Trastuzumab in Subjects with Metastatic Breast Cancer who have Progressed on a Previous Trastuzumab- Based Reg...