Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.

This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.

Inclusion Criteria:

• Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
• Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
• Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
• Subject with presence of measurable disease based on RECIST 1.1
• Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer

Exclusion Criteria:

• Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
• Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
• Subject with current active malignancy other than breast cancer
• Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
• Subject with significant renal or hepatic dysfunction
• Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
• Subject with insufficient bone marrow function
• Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
• Subject with current active bacterial, Hepatitis B or C, and/or HIV infections