A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
Summary
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
Arms & interventions
- DrugLY4064809
Administered orally
- DrugPlacebo
Administered orally
- DrugRibociclib
Administered orally
- DrugPalbociclib
Administered orally
- DrugAbemaciclib
Administered orally
- DrugAnastrozole
Administered orally
- DrugLetrozole
Administered orally
- DrugExemestane
Administered orally
- DrugFulvestrant
Administered intramuscular
Outcome measures
Primary
(Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)
As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Time frame: Baseline through disease progression or death (Estimated up to 5 years)
(Part 2): Progression-Free Survival
Investigator-assessed
Time frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)
Secondary
(Part 1): Disease Control Rate (DCR)
Time frame: Baseline through measured progressive disease (Estimated up to 5 years)
(Part 1): Time to Response (TTR)
Time frame: Baseline until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 5 years)
(Parts 1 and 2): Duration of Response (DOR)
Time frame: Date of CR or PR to date of objective disease progression or death due to any cause (Estimated up to 5 years)
(Part 1): PFS
Time frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)
(Parts 1 and 2): Overall Survival (OS)
Time frame: Baseline to deaths from any cause (Estimated up to 7 years)
(Part 1): Best Overall Response (BOR)
Time frame: Baseline to disease progression or death from any cause (Estimated up to 5 years)
(Parts 1 and 2): Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD Lasting Greater than or Equal to Six Months
Time frame: Baseline to disease progression or death from any cause (Estimated up to 5 years)
(Parts 1 and 2): PK: Average Plasma Concentrations of LY4064809
Time frame: Baseline to last PK sample collection up to 5 months
(Part 2): Progression-Free Survival after Subsequent Line of Treatment (PFS2)
Time frame: Baseline to disease progression on next line of treatment or death from any cause (Estimated as up to 7 years)
(Part 2): Progression-Free Survival (PFS)
Time frame: Baseline to objective progression or death from any cause (Estimated up to 5 years)
(Part 2): Objective Response Rate (ORR)
Time frame: Baseline to disease progression or death from any cause (Estimated up to 5 years)
(Part 2): Time to Chemotherapy (TTC)
Time frame: Baseline until the start of chemotherapy (Estimated up to 7 years)
(Part 2): Chemotherapy-Free Survival
Time frame: Baseline until the start of chemotherapy or death from any cause (Estimated up to 7 years)
(Part 2): Change in Overall Health-related Quality of Life (HRQoL) as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Subscale
Time frame: Baseline until disease progression or death (Estimated up to 7 years)
(Part 2): Change in Physical Function as measured by the EORTC QLQ-C30 Physical Functioning Subscale
Time frame: Baseline until disease progression or death (Estimated up to 7 years)
Eligibility criteria
Study locations (117)
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913
Highlands Oncology Group
Springdale, Arkansas, 72762
Community Cancer Institute
Clovis, California, 93611
City of Hope
Duarte, California, 91010
Marin Cancer Care
Greenbrae, California, 94904
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
Irvine, California, 92612
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Moores Cancer Center
La Jolla, California, 92093
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Kaiser Permanente Oakland
Oakland, California, 94611
Profound Research LLC
Oceanside, California, 92056
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Desert Regional Medical Center
Palm Springs, California, 92262
Stanford Cancer Center
Palo Alto, California, 94304
Kaiser Permanente
Roseville, California, 95661
Kaiser Permanente
San Francisco, California, 94115
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
Kaiser Permanente
Santa Clara, California, 95051
UCLA Hematology/Oncology - Parkside
Santa Monica, California, 90404
Providence Medical Foundation
Santa Rosa, California, 95403
Kaiser Permanente
Vallejo, California, 94589
Kaiser Permanente Walnut Creek
Walnut Creek, California, 94596
Cancer Centers of Colorado St. Mary's Regional Hospital
Grand Junction, Colorado, 81501
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, 80631
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, Colorado, 80538
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701
Clermont Oncology Center
Clermont, Florida, 34711
Florida Oncology & Hematology
Fort Myers, Florida, 33912
Mayo Clinic in Florida
Jacksonville, Florida, 32224
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612
Central Georgia Cancer Care
Macon, Georgia, 31210
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, 30265
Summit Cancer Care, PC
Savannah, Georgia, 31405
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
City of Hope, Chicago
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
Accellacare of Duly
Lisle, Illinois, 60532
Simmons Cancer Institute at SIU
Springfield, Illinois, 62702
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Deaconess Chancellor Center for Oncology
Newburgh, Indiana, 47630
University of Iowa
Iowa City, Iowa, 52242
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, 41017
Our Lady of the Lake RMC
Baton Rouge, Louisiana, 70808
New England Cancer Specialists
Westbrook, Maine, 04092
American Oncology Partners, PA
Bethesda, Maryland, 20817
James M Stockman Cancer Institute
Frederick, Maryland, 21702
Mass General Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757
Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital
South Weymouth, Massachusetts, 02190
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Profound Research LLC
Sterling Heights, Michigan, 48314
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, 38801
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Oncology Hematology Associates
Springfield, Missouri, 65807
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Jefferson Health - Cherry Hill
Cherry Hill, New Jersey, 08002
Sidney Kimmel Cancer Center - Washington Township
Sewell, New Jersey, 08080
Atlantic Health System Overlook Medical Center
Summit, New Jersey, 07901
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Messino Cancer Centers
Asheville, North Carolina, 28806
WakeMed Cancer Care - Waverly Hematology & Medical Oncology
Cary, North Carolina, 27518
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
Carolina Cancer Research Center
Wilson, North Carolina, 27893
Sanford Fargo Medical Center
Fargo, North Dakota, 58102
Cleveland Clinic Akron General
Akron, Ohio, 44302
Gabrail Cancer Center
Canton, Ohio, 44718
Fairview Hospital
Cleveland, Ohio, 44111
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
Oncology Associates of Oregon
Eugene, Oregon, 97401
Oregon Health and Science University
Portland, Oregon, 97239
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
Jefferson Hospital Northeast
Philadelphia, Pennsylvania, 19114
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Medical University of South Carolina
Charleston, South Carolina, 29425
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203
Nashville General Hospital
Nashville, Tennessee, 37208
Hendrick Medical Center
Abilene, Texas, 79601
World Research Link
Baytown, Texas, 77521
Parkland Health and Hospital System
Dallas, Texas, 75235
USO - Texas Oncology
Dallas, Texas, 75246
UT Southwestern Medical Center
Dallas, Texas, 75390
Texas Oncology - West Texas
El Paso, Texas, 79902
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
Houston Methodist Hospital
Houston, Texas, 77030
Oncology Consultants P.A.
Houston, Texas, 77030
Nova Oncology
McAllen, Texas, 78504
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240
US Oncology Research Network
The Woodlands, Texas, 77380
Tranquility Research
Webster, Texas, 77598
Utah Cancer Specialists
Salt Lake City, Utah, 84106
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05405
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Providence Regional Cancer Partnership
Everett, Washington, 98201
UW Medicine Valley Medical Center
Renton, Washington, 98055
Swedish Medical Center
Seattle, Washington, 98104
Deaconess Hospital
Spokane, Washington, 99204
Cancer Care Northwest - Vercler
Spokane Valley, Washington, 99216
MultiCare Health System
Tacoma, Washington, 98405
North Star Lodge
Yakima, Washington, 98902
ThedaCare Physicians - Appleton North
Appleton, Wisconsin, 54911