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