Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer

Exclusion Criteria

• •Brain metastases
• •Another primary malignancy within 3 years prior to starting drug therapy with the exception of adequately treated in-site carcinoma of the uterine cervix or skin cancer
• •Chemotherapy within 3 weeks prior to starting study drug or not recovered from side effects of previous therapy
• •Administration of nitrosurea or mitomycin-C within 6 weeks prior to starting study drug or not recovered from side effects of such therapy
• •Administration of biologic therapy within 6 weeks prior to starting study drug or not recovered from side effects of such therapy
• •Radiotherapy within 4 weeks prior to starting study drug or 2 weeks in the case of localized radiotherapy or not recovered from radiotherapy toxicities
• •major surgery, open biopsy or significant traumatic injury within 4 weeks prior to starting study drug or a minor procedure, percutaneous biopsy or placement of a vascular access device within 1 week prior to starting study drug or not recovered from side effects of such procedure or injury
• •Chronic concomitant bisphosphonate therapy for the prevention of bone metastases. Bisphosphonate/ denosumab therapy for the management of bone metastases or for the treatment of osteoporosis s allowed.
• •Impaired cardiac function or clinically significant cardiac disease
• •Impairment of GI function or GI disease that may significantly alter the absorption of dovitinib
• •Cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
• •Known diagnosis of HIV infection
• •Anticoagulation treatment with therapeutic doses of warfarin
• •Any concurrent severe and/or uncontrolled concomitant medical condition that could cause unacceptable safety risks or compromise compliance with the protocol
• •Pregnant or breast-feeding
• •Unwilling or unable to comply with the protocol