The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Number of Participants with DLTs and DLT-Equivalent Toxicities
Time frame: Baseline through Cycle 1 (21/28 Day Cycle)
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356
PK: AUC of LY3484356
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
PK: Maximum Concentration (Cmax) of LY3484356
PK: Cmax of LY3484356
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
PK: AUC of LY3484356 in Combination with Other Anticancer Therapies
PK: AUC of LY3484356 in Combination with Other Anticancer Therapies
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies
PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR: Percentage of Participants with Confirmed CR or PR as per RECIST v1.1
Time frame: Baseline through Disease Progression or Death (Estimated up to 28 Months)
Duration of Response (DoR): Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier
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Administered orally
Administered intravenously
Anastrozole or Exemestane or Letrozole administered orally (physician choice)
Administered intravenously
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
University of California, Irvine
Orange, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Lake Nona DDU
Orlando, Florida, United States
Winship Cancer Center Emory University
Atlanta, Georgia, United States
Community Cancer Center North
Indianapolis, Indiana, United States
...and 64 more locations
DoR: Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 28 Months)
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response (BOR) of CR, PR, and Stable Disease (SD) as per RECIST v1.1
DCR: Percentage of Participants with a BOR of CR, PR, and SD as per RECIST v1.1
Time frame: Baseline through Measured Progressive Disease (Estimated up to 28 Months)
Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1
CBR: Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1
Time frame: Baseline through Measured Progressive Disease (Estimated up to 28 Months)
Progression Free Survival (PFS): Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier
PFS: Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 28 Months)