NSABP FB-7: A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens with Weekly Paclitaxel plus Neratinib or Trastuzumab or Neratinib or Trastuzumab Followed by Doxorubicin and Cyclophosphamide with Postoperative Trastuzumab in Women with Locally Advanced HER2-Positive Breast Cancer

Primary aim and endpoint
Aim: To determine the pathologic complete response rate in breast and axillary lymph nodes(pCR breast and nodes) for patients with HER2-positive LABC following neoadjuvant therapy which consists of paclitaxel/trastuzumab followed by AC VS paclitaxel/neratinib followed by AC
Endpoint: pCR breast and nodes
Secondary aims and endpoints
3.2.1 Pathologic complete response in breast (pCR breast)
Aim: To determine the pCR rate in breast in patients with LABC
Endpoint: pCR breast
3.2.2 Clinical complete response (cCR)
Aim: To determine the cCR rate in patients with LABC who present with palpable
disease
Endpoint: cCR assessed by physical exam at the completion of paclitaxel (before AC)
Endpoint: cCR assessed by physical exam at the completion of AC (before surgery)
3.2.3 Recurrence-free interval (RFI)
Aim: To determine 2-year RFI
Endpoint: Events for analysis of RFI include inoperable progressive disease and local,
regional, and distant recurrence during the 2 years from randomization.
3.2.4 Overall survival (OS)
Aim: To determine 2-year OS
Endpoint: Time from randomization until death from any cause
Toxicity
Aim: To determine toxicities of the FB-7 regimens
Endpoint: Reported toxicities, including cardiotoxicity, as defined by CTCAE v3.0
3.2.6 Correlative science studies
Aim: To explore molecular and genetic correlates of response

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.