EUCTR2010-023763-17-BE
Active, not recruiting
Phase 1
A phase II double-blind placebo-controlled randomized study of GDC-0941 or GDC-0980 with Fulvestrant versus Fulvestrant in advanced or metastatic breast cancer in patients resistant to aromatase inhibitortherapy
ConditionsAdvanced or metastatic breast cancer resistant to aromatase inhibitor therapyMedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsFaslodex
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced or metastatic breast cancer resistant to aromatase inhibitor therapy
- Sponsor
- Genentech, Inc.
- Enrollment
- 260
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \= 18 years
- •2\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •3\. Postmenopausal women with locally advanced breast cancer previously treated with an aromatase inhibitor (AI)
- •4\. ER\-positive disease and HER2\-negative disease
- •5\. Measurable disease or non\-measurable disease
- •6\. Adequate hematologic and end\-organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 143
Exclusion Criteria
- •1\. Prior treatment with fulvestrant, PI3K inhibitor, or mTOR inhibitor for advanced breast cancer or MBC
- •2\. Prior anti\-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
- •3\. Prior treatment with \> 1 cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on \> 2 endocrine therapies for MBC
- •4\. Patients requiring anti\-hyperglycemic therapy
- •5\. Clinically significant cardiac or pulmonary dysfunction
- •6\. Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus, or hepatitis C virus
- •7\. Need for current chronic corticosteroid therapy
- •8\. Known untreated or active CNS metastases
Outcomes
Primary Outcomes
Not specified
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