Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer

A Phase 1/2, Modified Dose Escalation, Open Label Trial to Determine the Therapeutic Effect and Safety of INCB007839 Combined With Trastuzumab in Patients With Previously Untreated HER2 Positive Metastatic Breast Cancer

This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive
• Measurable disease as defined by the RECIST criteria
• Life expectancy greater than or equal to 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Received any anticancer medications in the 28 days prior to enrollment into this study
• Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
• History of deep venous thrombosis within the last year
• Contraindication to low dose warfarin therapy
• Clinically significant cardiomyopathy
• Prior treatment with INCB007839 or trastuzumab or lapatinib