A Phase Ib, Open-Label, Dose-Escalation Study of the Safety And Pharmacology of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer
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 Response Evaluation Criteria in Solid
Tumors (RECIST)
- Agreement to use an effective form of contraception for the duration of the study
Exclusion Criteria:
- History of Grade >/= 3 fasting hyperglycemia
- History of diabetes requiring regular medication
- 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, or hormonal therapy)
within a specified timeframe of the first dose of study treatment
- Uncontrolled current illness
- Active autoimmune disease requiring the equivalent of >10 mg/day of prednisone
- Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, or current known active infection with 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
- No prior taxane therapy for metastatic disease