drugset / Trial / NCT03812393
Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast
Phase 2
Unknown
27 enrolled
West Cancer Center
Celcuity Inc · collabPuma Biotechnology, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Neratinib Followed by Weekly Paclitaxel and Carboplatin Plus Neratinib in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)
Timeline
- Start
- 2019-06-21
- Primary completion
- 2024-12-15
- Completion
- 2024-12-15
Publications
- Results Huang Y, Burns DJ, Rich BE, MacNeil IA, Dandapat A, Soltani SM, Myhre S, Sullivan BF, Furcht LT, Lange CA, Hurvitz SA, Laing LG. A functional signal profiling test for identifying a subset of HER2-negative breast cancers with abnormally amplified HER2 signaling activity. Oncotarget. 2016 Nov 29;7(48):78577-78590. doi: 10.18632/oncotarget.12480.
- Results Huang Y, Burns DJ, Rich BE, MacNeil IA, Dandapat A, Soltani SM, Myhre S, Sullivan BF, Lange CA, Furcht LT, Laing LG. Development of a test that measures real-time HER2 signaling function in live breast cancer cell lines and primary cells. BMC Cancer. 2017 Mar 16;17(1):199. doi: 10.1186/s12885-017-3181-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neratinib | Small molecule | 240 mg | — |