674
Participants
Start Date
March 16, 2011
Primary Completion Date
June 25, 2021
Study Completion Date
June 25, 2021
Fulvestrant
Participants will receive fulvestrant 500 milligrams (mg) via intramuscular injection (as per package insert or Summary of Product Characteristics \[SmPC\]) on Days 1 and 15 of Cycle 1, then on Day 1 of each subsequent cycle, until disease progression (Cycle length: 28 days).
GDC-0032
Participants will receive GDC-0032 at escalating (Phase I, Stage 1) or fixed (Phase II and Phase I, Stage 2) doses until disease progression. Cycle 1 may be 35 days in length to allow for a 7-day washout following the initial dose; thereafter, GDC-0032 will be administered orally once daily in 28-day cycles.
Letrozole
Participants will receive letrozole 2.5 mg orally (as per Package Insert or SmPC) once daily in 28-day cycles until disease progression.
Midazolam
Participants will receive midazolam 5 mg (as per Package Insert or SmPC) in hydrochloride syrup on Days 1 and 16 of Cycle 1.
Memorial Sloan-Kettering Cancer Center, New York
New York Oncology Hematology, P.C., Albany
Sarah Cannon Res Inst; FL, Sarasota
Sarah Cannon Res Inst; TN Onc, Nashville
Vanderbilt Breast Center; Vanderbilt Health Pharmacy, Nashville
Vanderbilt, Nashville
West Cancer Center, Germantown
Hospital Clinico Universitario de Valencia, Valencia
Univ of Chicago, Chicago
Washington University; Division of Oncology, St Louis
Sarah Cannon Res Inst; OK, Oklahoma City
Mary Crowley Cancer Rsch Ctr, Dallas
Baylor Sammons Cancer Center, Dallas
USO - Tyler Cancer Ctr, Tyler
MD Anderson Cancer Center, Houston
TGen Clinical Research Srvs, Scottsdale
University of Arizona Cancer Center, Tucson
University of California Irvine Medical Center, Orange
Sutter Health, San Francisco
Institut Gustave Roussy, Villejuif
UC Davis; Comprehensive Cancer Center, Sacramento
Northwest Cancer Specialists - Vancouver, Vancouver
Yakima Valley Memorial Hospital/North Star Lodge, Yakima
Yale University, New Haven
Florida Cancer Specialists - Fort Myers (New Hampshire Ct), Fort Myers
Barbara Ann Karmanos Cancer Institute, Detroit
Massachusetts General Hospital Cancer Center, Boston
Dana Farber Cancer Inst., Boston
Texas Cancer Center, Abilene
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de la Barca
Lead Sponsor
Genentech, Inc.
INDUSTRY