200
Participants
Start Date
December 13, 2016
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
Inavolisib
Participants will receive oral inavolisib once daily on Days 1-28 of each 28-day cycle (Arms A, B, C, D, E, F) or Days 1-21 of each 21-day cycle (Arm G).
Fulvestrant
Participants will receive fulvestrant 500 mg, administered intramuscularly on Days 1 and 15 of Cycle 1. For subsequent cycles, participants will receive fulvestrant intramuscularly on Day 1 of each cycle.
Letrozole
Participants will receive once daily oral doses of letrozole 2.5 mg on Days 1-28 of each cycle.
Palbociclib
Participants will receive once daily oral doses of palbociclib 125 mg on Days 1-21 of each cycle.
Metformin
Participants will receive oral metformin once daily, starting on Cycle 1, Day 1, as tolerated.
Trastuzumab
Participants will receive trastuzumab, administered by IV infusion on Day 1 of each 21-day cycle, at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles, until disease progression or unacceptable toxicity.
Pertuzumab
Participants will receive pertuzumab, administered by IV infusion on Day 1 of each 21-day cycle, at a loading dose of 840 mg for Cycle 1 and a dose of 420 mg for subsequent cycles, until disease progression or unacceptable toxicity.
Columbia University Medical Center, New York
Institut Bergonie, Bordeaux
SCRI Oncology Partners, Nashville
Institut Gustave Roussy, Villejuif
Dana Farber Cancer Institute, Boston
Princess Margaret Hospital, Toronto
Hospital Universitari Vall d'Hebron, Barcelona
Royal Marsden Hospital - Surrey, Surrey
St Bartholomew's Hospital, London
Royal Marsden Hospital - London, London
Lead Sponsor
Genentech, Inc.
INDUSTRY