Advanced or metastatic breast cancer resistant to aromatase inhibitor therapy MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Code: GDC-0941/RO5314482
Pharmaceutical Form: Film-coated tablet
CAS Number: 957054-33-0
Current Sponsor code: GDC-0941/RO5314482
Other descriptive name: GDC-0941.180
Concentration unit: mg mi
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 117
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy (as measured by PFS) of fulvestrant + GDC-0941 versus fulvestrant + placebo •To evaluate the safety of fulvestrant+GDC 0941 and fulvestrant + GDC 0980 versus fulvestrant + placebo ;Secondary Objective: •To assess the clinical activity, as measured by response rate, duration of response, and CBR of fulvestrant + GDC 0941 versus fulvestrant + placebo • To assess the prognostic effects of PIK3CA mutations on PFS in patients with ER-positive advanced breast cancer ;Primary end point(s): PFS, defined as the time from the first dose of fulvestrant on Cycle 1 Day 1 to the first observation of disease progression as assessed by the investigator per modified RECIST version 1.1 (v1.1) or death from any cause on study (<= 30 days after the last dose of study treatment);Timepoint(s) of evaluation of this end point: Tumor assessments at end of Cycles 2, 4, 6 and 8 and every 3 cycles thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Objective tumor response as assessed by the investigator per modified RECIST v1.1 - Clinical benefit defined as PR, CR, or stable disease, lasting for at least 6 months (i.e., 26 weeks) - Duration of confirmed objective response, defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator per modified RECIST v1.1 - The mutational status of PIK3CA and the presence of complete loss of the PTEN as determined by IHC;Timepoint(s) of evaluation of this end point: Tumor assessments at end of Cycles 2, 4, 6 and 8 and every 3 cycles thereafter | — |
Countries
Australia, Belgium, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, Russian Federation, Singapore, Spain, Thailand, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed