This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
183
GDC-0941 will be administered QD orally for 5 consecutive days each week.
Placebo matching to GDC-0941
Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Time frame: From the time of randomization until disease progression or death from any cause (up to approximately 3 years)
Percentage of Participants With Adverse Events
Time frame: From randomization up to approximately 3 years
Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1
Time frame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Percentage of Participants Acheiving Clinical Benefit (Partial Response, Complete Response or Stable Disease Lasting for at Least 6 Months) Assessed as per Modified RECIST v1.1
Time frame: From randomization until disease progression (up to approximately 3 years)
Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1
Time frame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Population Pharmacokinetics (PK) for GDC-0941
Time frame: Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)
Population PK for Paclitaxel
Time frame: Day 1 of Cycle 1 (cycle length=28 days)
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Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States
Pacific Cancer Medical Center
Anaheim, California, United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States
Kaiser Permanente - Hayward
Hayward, California, United States
Kaiser Permanente - Oakland
Oakland, California, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
Kaiser Permanente - San Francisco (2238 Geary)
San Francisco, California, United States
University of California at San Francisco
San Francisco, California, United States
...and 87 more locations