Phase
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
Adequate organ and bone marrow function as assessed by laboratory tests
Evaluable disease or disease measurable per RECIST
Agreement to use an effective form of contraception for the duration of the study
Exclusion
Exclusion Criteria:
History of malabsorption syndrome or other condition that would interfere with enteralabsorption
Any condition requiring full-dose anticoagulants, such as warfarin, heparin, orthrombolytic agents
Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, radiotherapy, orhormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the firstdose of study treatment
Uncontrolled current illness
Active small or large intestine inflammation (such as Crohn's disease or ulcerativecolitis)
Clinically significant history of liver disease, including cirrhosis, current alcoholabuse, or current known active infection with human immunodeficiency virus (HIV),hepatitis B virus, or hepatitis C virus
Known HIV infection
New York Heart Association (NYHA) Class II or greater congestive heart failure
Active ventricular arrhythmia requiring medication
Pregnancy, lactation, or breastfeeding
Known significant hypersensitivity to study drugs or excipients
History of arterial thromboembolic disease within 6 months of first study treatment
No more than two prior chemotherapy regimens for metastatic disease
Study Design
Connect with a study center
Leuven, 3000
BelgiumSite Not Available
Milano, Lombardia 20133
ItalySite Not Available
Peoria, Illinois 61615
United StatesSite Not Available
Boston, Massachusetts 02115
United StatesSite Not Available
Nashville, Tennessee 37232
United StatesSite Not Available
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