Phase 2
Completed N=52
Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer · TNBC - Triple-Negative Breast Cancer
Source: ClinicalTrials.gov NCT03057600 ↗
Enrolled (actual)
52
Serious AEs
21.2%
Results posted
Sep 2022
Primary outcomePrimary: Overall Response Rate (ORR) — 22.2; 10.0; 10.5; 53.8 percentage of participants — p=0.2252
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
22.2; 10.0; 10.5; 53.8 | 0.2252 |
| SECONDARY Progression Free Survival (PFS) as Assessed by Investigator |
2.30; 5.49; 2.00; 7.33 | — |
| SECONDARY Overall Survival (OS) |
7.26; 13.47; 6.44; 16.76 | — |
| SECONDARY Duration of Response (DOR) |
NA; 6.47; 7.61; 11.04 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
22.2; 20.0; 10.5; 61.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT03057600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.