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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
920
Administered orally
Administered orally
Administered orally
Administered orally
Administered orally
Administered orally
Administered orally
Administered orally
Administered intramuscular
Alaska Oncology and Hematology
Anchorage, Alaska, United States
NOT_YET_RECRUITINGIronwood Cancer & Research Centers
Chandler, Arizona, United States
NOT_YET_RECRUITINGMayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
NOT_YET_RECRUITINGThe University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
NOT_YET_RECRUITING(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)
(Part 1): Disease Control Rate (DCR)
per RECIST v1.1
Time frame: Baseline through measured progressive disease (Estimated up to 5 years)
(Part 1): Time to Response (TTR)
per RECIST v1.1
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)
per RECIST v1.1
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
per RECIST v1.1
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
per RECIST v1.1
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)
Investigator-assessed
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)
By BICR
Time frame: Baseline to objective progression or death from any cause (Estimated up to 5 years)
(Part 2): Objective Response Rate (ORR)
By investigator and blinded independent central review (BICR)
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
The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale (two items). Response options range from 1) "very poor" to 7) "excellent." Score is linearly transformed to the range 0 - 100. Higher score represents better overall HRQoL.
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
The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Physical function is measured by the EORTC QLQ-C30 Physical Functioning subscale (five items). Response options range from 1) "not at all" to 4) "very much." Score is linearly transformed to the range 0 - 100. Higher score represents better overall physical function.
Time frame: Baseline until disease progression or death (Estimated up to 7 years)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
NOT_YET_RECRUITINGHighlands Oncology Group
Springdale, Arkansas, United States
RECRUITINGCity of Hope
Duarte, California, United States
NOT_YET_RECRUITINGMarin Cancer Care
Greenbrae, California, United States
RECRUITINGChao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
Irvine, California, United States
NOT_YET_RECRUITINGCity of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
NOT_YET_RECRUITING...and 307 more locations