WOMEN WITH ER-POSITIVE AND HER2-NEGATIVE, LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAS DIDEASE RECURRENCE OR PROGRESSION DURING OR AFTER AROMATASE INHIBITOR THERAPY MedDRA version: 17.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen-receptor positive (ER+) breast cancer - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study - Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer - Recurrence or progression during or after aromatase inhibitor - Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Consent to provide tumor tissue (block or a minimum of 20 slides) from the most recent tumor tissue for PIK3CA-mutation testing; a valid cobas PIK3CA mutation result by central testing is required - Adequate hematologic and end-organ function within 28 days prior to treatment initiation 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 390 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 210
Exclusion criteria
Exclusion criteria: - HER2-positive disease by local laboratory testing (immunohistochemistry [IHC] 3+ staining or in situ hybridization positive) - Prior treatment with fulvestrant - Prior treatment with a PI3K inhibitor, mTOR inhibitor (e.g. everolimus), or AKT inhibitor - Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1 - Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1 - All acute treatment-related toxicity must have resolved to Grade 1 cytotoxic chemotherapy regimen for metastatic breast cancer - Concurrent hormone replacement therapy - Known untreated or active central nervous system (CNS) metastases - Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications - History of inflammatory bowel disease or active bowel inflammation - Clinically significant cardiac or pulmonary dysfunction - Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy between taselisib plus fulvestrant versus placebo plus fulvestrant as measured by investigator-assessed progression-free survival (PFS) in patients with PIK3CA mutant tumors;Secondary Objective: The secondary objectives of this study are the following: •To evaluate the safety of taselisib plus fulvestrant versus placebo plus fulvestrant. •To compare the efficacy between taselisib plus fulvestrant versus placebo plus fulvestrant as measured by OS in patients with PIK3CA mutant tumors. •To compare the overall objective response rate (ORR) and clinical benefit rate (CBR), and estimate the duration of response (DOR) between taselisib plus fulvestrant versus placebo plus fulvestrant in patients with PIK3CA mutant tumors, based on investigator assessment.;Primary end point(s): Progression-free survival (PFS), as determined by the investigator with the use of RECIST version 1.1;Timepoint(s) of evaluation of this end point: Up to approximately 3.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival 2. Overall objective response (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1 3. Clinical benefit, defined as objective response (PR+CR), or stable disease (SD) lasting for at least 24 weeks since randomization 4. Duration of objective response 5. Incidence of adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 ;Timepoint(s) of evaluation of this end point: 1 to 5. Up to approximately 3.5 years | — |
Countries
Australia, Austria, Bulgaria, Canada, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Turkey, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed