BREAST: NEOADJUVANT: Triple Negative: BIOMARKER SPECIFIC: FACT-2

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)

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)

Site Link
Malignancy
Breast, Triple Negative Breast Cancer
Stage
Disease Setting
Neoadjuvant/Curative
Line Of Therapy
Neoadjuvant
Investigational Agent
Neratinib
Drug Class
HER2 targeted small molecule
PI
Greg Vidal, MD, PhD
Sponsor
West Cancer Center, Puma Biotechnology, Celcuity
Phase
Status
Key Eligibility Criteria
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
Objective
  • Primary- % of patients experiencing >=20% response to niratinib monotherapy; pCR rate
  • Secondarty- Clinical complete response rate, residual cancer burden 0-1 rate, safety, web-based symptom monitoring
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
ER negative, PR negative, HER2 negative
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
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