Patients with Advanced Triple Negative Breast Cancer

Status: open

A Multicenter Phase 2 Study of the Glutaminase Inhibitor CB-839 in Comination with Paclitaxel in Patients with Advanced Triple Negative Breast Cancer (TNBC) Including Patients of African Ancestry and Non-African Ancestry

Treatment for Breast Cancer

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Description

Inclusion Criteria: Meets criteria for 1 of the 4 defined study cohorts; TNBC defined as ER and PR negative (<1%) and HER-2 negative (FISH negative or IHC 0-1+); Metastatic disease or locally-advanced disease not amenable to curative intent treatment; Adequate hepatic, renal, cardiac, and hematologic function; ECOG performance status 0-1; Recovery to baseline or ≤ Grade 1 CTCAE. Exclusion Criteria: Known brain metastases or CNS cancer unless adequately treated with radiotherapy and/or surgery and stable for ≥ 2 mo; Unable to receive oral medications; Known hypersensitivity to Cremophor®-based agents; Major surgery within 28 days of C1D1.

Sponsors

This trial is sponsored by Calithera.

Providers Associated With This Trial

Sub Investigators

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