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.

INCYTE Corporation, USA0 sites60 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

No summary available.

•Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive as defined by positive fluorescent in situ hybridization (FISH)
•-Left ventricular ejection fraction (LVEF) by either MUGA scan or echocardiography that is considered to be within the normal limits as defined by the testing laboratory

•-Received prior chemotherapy for metastatic breast cancer (Adjuvant or neoadjuvant chemotherapy is allowed.)(Hormonal therapy is allowed both as adjuvant therapy and as therapy for metastatic disease and stable ongoing hormonal therapy is allowed to be continued during this study.)
•-History of deep venous thrombosis within the last year
•-Presence of deep venous thrombosis on screening Doppler
•-Contraindication to low dose warfarin therapy
•-Contraindication to low dose aspirin therapy
•-History of clinically significant Cardiomyopathy
•-Malabsorption syndrome, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
•-Prior treatment with INCB007839 or trastuzumab or lapatinib.
•-Prior hypersensitivity reaction to drugs formulated with polysorbate-80.

Sponsor

INCYTE Corporation, USA