Clareo Health | Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Calithera Biosciences, Inc
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
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Known brain metastases or central nervous system (CNS) cancer unless adequately treated with radiotherapy and/or surgery and stable for ≥ 2 mo
