A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer
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Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
History of malabsorption syndrome or other condition that would interfere with enteral absorption
Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, radiotherapy, or hormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study treatment
Uncontrolled current illness
Active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis)
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, 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
Clareo Health | A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer
