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Clinical Trial Summary

This is a multicenter, open-label, non-comparative, three-arm, phase IIa trial of Ipatasertib (GDC-0068) in combination with non-taxane chemotherapy agents for taxane-pretreated unresectable locally advanced or metastatic triple-negative breast cancer patients


Clinical Trial Description

Women age ≥ 18 years with triple-negative unresectable locally advanced or MBC that is not amenable to resection with curative intent. Patients must have received at least one, but not more than two, prior chemotherapeutic regimens for treatment of unresectable locally advanced and/or metastatic disease (at least one regimen must have contained a taxane). The number of patients to be included is 54 patients. The primary objective is to evaluate the safety and tolerability of ipatasertib (GDC-0068) in combination with capecitabine, eribulin, or carboplatin plus gemcitabine in patients with unresectable locally advanced or metastatic triple-negative breast cancer ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04464174
Study type Interventional
Source MedSIR
Contact
Status Completed
Phase Phase 2
Start date October 8, 2020
Completion date November 10, 2023

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