Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy
Status: Recruiting
Phase:
Diagnosis: Breast: Early Stage Disease, Breast: Metastatic
NCT ID: NCT01437566
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-331
This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial with three study arms. Patients with advanced or Metastatic Breast Cancer (MBC) whose disease is resistant to aromatase inhibitor (AI) therapy will be enrolled in this study.
Conducting Institutions:
Dana-Farber Cancer Institute
Overall PI:
Philip Kantoff, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Postmenopausal women with locally advanced breast cancer or Metastatic Breast Cancer
(MBC) whose disease is resistant to Aromatase Inhibitor (AI) therapy
- Patients must have measurable disease by RECIST v1.1 or non-measurable disease
- Adequate hematologic and end-organ function
Exclusion Criteria:
- Prior treatment with fulvestrant, PI3K inhibitor, or mTOR inhibitor for advanced
breast cancer or MBC
- History of clinically significant cardiac or pulmonary dysfunction
- History of malabsorption syndrome or other condition that would interfere with
enteral absorption
- Clinically significant history of liver disease
- Active autoimmune disease or active inflammatory disease
- Immunocompromised status
- Need for current chronic corticosteroid therapy
- Pregnancy, lactation, or breastfeeding
- Current severe, uncontrolled systemic disease
- Known untreated or active central nervous system (CNS) metastases
Other protocol-defined inclusion/exclusion criteria may apply.