Title
WCC 2018-002 (Celcuity- Neoadjuvant Breast)
Study Title
Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)
Malignancy
Breast, Triple Negative Breast Cancer
Drug Class
HER2 targeted small molecule
Sponsor
West Cancer Center, Puma Biotechnology, Celcuity
Key Eligibility Criteria Details
- T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
- ER/PR <10%, HER2 negative
- ECOG PS 0-1
- ANC >1200, Hgb >10, Plt >100,000
- Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
- No T3 or T4 tumors
- No definitive surgical treatment performed yet
- No evidence of metastatic disease
- No prior history of ipsilateral DCIS or breast cancer
- No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
- No other malignancies within 2 years prior
- No active cardiac disease
- No uncontrolled hypertension
- No known HIV/HBV/HCV
- No neuropathy grade >=2