Breast Cancer Clinical Trial
Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
Summary
CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in participants of African ancestry and non-African ancestry with advanced triple negative breast cancer. Multiple single-arm cohorts will be enrolled in which 800 mg twice daily (BID) CB-839 will be administered in combination with the full approved dose of paclitaxel.
Full Description
Participants will be enrolled into 4 cohorts, as follows:
Cohort 1: patients of African ancestry with 2 or more lines of prior therapy for metastatic disease
Cohort 2: patients of African ancestry with no prior lines of therapy for metastatic disease
Cohort 3: same as cohort 1 but in patients of non-African ancestry
Cohort 4: same as cohort 2 but in patients of non-African ancestry
Eligibility Criteria
Key Inclusion Criteria:
Meets criteria for 1 of the 4 defined study cohorts
TNBC, defined as estrogen receptor (ER) and progesterone receptor (PR) negative (< 1% by immunohistochemistry) and human epidermal growth factor receptor 2 (HER2)-negative (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization [FISH] negative)
Metastatic disease or locally-advanced disease not amenable to curative intent treatment
Adequate hepatic, renal, cardiac, and hematologic function
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Recovery to baseline or ≤ Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version.4.0
Key Exclusion Criteria:
Known brain metastases or central nervous system (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 Cycle 1 Day 1
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There are 24 Locations for this study
Birmingham Alabama, 35294, United States
Mobile Alabama, 36604, United States
New Haven Connecticut, 06511, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20010, United States
Miami Florida, 33176, United States
Tampa Florida, 33612, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30332, United States
Marietta Georgia, 30060, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21237, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New York New York, 10032, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Charleston South Carolina, 29414, United States
Greenville South Carolina, 29605, United States
Germantown Tennessee, 38138, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Tacoma Washington, 98405, United States
Milwaukee Wisconsin, 53226, United States
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