Clareo Health | Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Locally recurrent or metastatic breast cancer, not amenable to resection with curative intent
For Arm C: Overexpression of HER2
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Adequate hematologic and organ function
Evaluable or measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors)
Female patients of childbearing potential must use an acceptable method of contraception to prevent pregnancy and to continue its use for the duration of the study
You may not be if
Prior anti-cancer therapy of more than two regimens of systemic cytotoxic chemotherapy for advanced or metastatic breast cancer
Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
History of Type 1 or Type 2 diabetes requiring regular medication
History of clinically significant cardiac or pulmonary dysfunction
History of malabsorption syndrome or other condition that would interfere with enteral absorption
Any condition requiring full-dose anticoagulants
Leptomeningeal disease as a manifestation of cancer
Active infection requiring IV antibiotics
Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs, inhaled steroids, or the equivalent of \<= 10 mg/day of prednisone
Known clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
Known HIV infection
Known untreated or active CNS metastases
Pregnancy, lactation, or breastfeeding
Major surgical procedure, open biopsy, or significant traumatic injury within a within a specified timeframe of the first dose of study treatment
For Arm B:
Uncontrolled hypertension, complication from hypertension, myocardial infarctions, unstable angina, vascular disease or stroke within a specified timeframe of the first dose of study treatment
Evidence of bleeding diathesis or significant coagulopathy including hemoptysis within a specified timeframe of the first dose of study treatment
History of abdominal conditions (e.g., fistula, perforation, obstruction) that would preclude use of bevacizumab
Serious, non-healing wound, active ulcer, or untreated bone fracture
