An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)
Clinical Trial Information
Trial Contact: Jobson, Gillian S; Morales, Leticia
IRB No: 18.057.04
Protocol Abbrev: NSABP-FB12
Principal Investigator: Nikita Chandrakant Shah, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: FB-12
Treatment: Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT03412643
To evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity HSF testing.
• Medical oncologist has indicated the intention to administer doxorubicin/cyclophosphamide followed by paclitaxel.
• All patients will be required to have a research core biopsy procedure to procure fresh tumor tissue for pre-entry central HER2 signaling testing by Celcuity
• Patients must be female, ≥ 18 years old. The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.