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

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Trastuzumab; Vinblastine; Vinorelbine

Criteria

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