252
Participants
Start Date
January 13, 2021
Primary Completion Date
December 4, 2023
Study Completion Date
February 27, 2024
Entrectinib
Entrectinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 600 milligrams (mg) per day once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.
Inavolisib
Inavolisib will be self-administered by participants orally at home (except on clinic days) at the same time each day, on a starting dose of 9 mg/day QD until disease progression, intolerable toxicity, or consent withdrawal.
Alectinib
Alectinib will be self-administered by participants orally at home (except on clinic days), at the same times each day, on a starting dose of 600 mg twice a day (BID) until disease progression, intolerable toxicity, or consent withdrawal.
Ipatasertib
Ipatasertib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg QD until disease progression, intolerable toxicity, or consent withdrawal.
Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg for participants on Day 1 of each 21-day cycle until unacceptable toxicity or progressive disease (or loss of clinical benefit).
Trastuzumab Emtansine
Trastuzumab emtansine will be administered at 3.6 mg per kilogram (kg) of body weight by IV infusion every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab once every 3 weeks.
Tucatinib
Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.
Investigator's Choice of Chemotherapy
Chemotherapy will consist of docetaxel, paclitaxel, or capecitabine, as determined by the investigator, and will be administered per the respective package insert and institutional guidelines.
Paclitaxel
The dose of paclitaxel is 80 mg/m2 administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. The paclitaxel infusion will be delivered over at least 60 minutes for each dose per institutional guidelines and administered after the oral dose of ipatasertib.
Tiragolumab
Following the administration of atezolizumab and an observation period, participants will receive 600 mg tiragolumab at a fixed dose administered by IV infusion on Day 1 of each 21-day cycle.
Pralsetinib
Pralsetinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg/day (four 100-mg capsules per day) once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.
Eastchester Center for Cancer Care, The Bronx
New York Cancer & Blood Specialists, The Bronx
Virginia Commonwealth University - Massey Cancer Center, Richmond
Messino Cancer Centers, Asheville
Florida Cancer Specialists - PAN - SCRI - PPDS, Tallahassee
SCRI Florida Cancer Specialists South, Fort Myers
SCRI Oncology Partners, Nashville
Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga
The West Clinic, PC dba West Cancer Center, Memphis
SCRI Mark H. Zangmeister Center, Columbus
Gabrail Cancer Center, Canton
Tri County Hematologyoncology, Canton
Ascension St. John Hospital, Detroit
Frontier Cancer Center and Blood Institute, Billings
Hematology and Oncology Clinic, Baton Rouge
Genesis Cancer Center, Hot Springs
Mays Cancer Center at UT Health San Antonio MD Anderson Cancer, San Antonio
St Luke?s Cancer Institute, Boise
Los Angeles Hematology Oncology Medical Group, Los Angeles
Sarcoma Oncology Center, Santa Monica
Ventura County Hematology Oncology Specialists, Ventura
Pacific Cancer Care - Monterey, Monterey
Kaiser Permanente - San Francisco Medical Center, San Francisco
Kaiser Permanente Medical Ctr, Vallejo
Kaiser Permanente Center For Health Research, Portland
Northwest Medical Specialties B, Federal Way
Alaska Oncology and Hematology, Anchorage
Arizona Clinical Research Ctr, Oro Valley
California Cancer Associates for Research and Excellence - Encinitas, Encinitas
Eastern CT Hematology and Oncology Associates, Norwich
Florida Cancer Specialists - NORTH - SCRI - PPDS, St. Petersburg
Florida Cancer Specialists - EAST - SCRI - PPDS, West Palm Beach
Saint Agnes Hospital - Baltimore - Hunt - PPDS, Baltimore
Southeast Nebraska Cancer Center, Lincoln
New Jersey Hematology Oncology Associates LLC, Brick
Astera Cancer Care East Brunswick, East Brunswick
Central Park Hematology and Oncology, New York
The Center for Cancer and Blood Disorders - PPDS, Fort Worth
Lead Sponsor
Genentech, Inc.
INDUSTRY