The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
City of Hope National Medical Center
Duarte, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Number of Participants with Dose Reductions
Number of Participants with Dose Reductions
Time frame: Baseline through Cycle 1 (28 Day Cycle)
Part II: Number of Participants with Dose Limiting Toxicities (DLTs)
Part II: Number of Participants with DLTs
Time frame: Baseline through Cycle 1 (28 Day Cycle)
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR
Time frame: Baseline through Measured Progressive Disease (Estimated up to 23 Months)
Duration of Response (DoR)
DoR
Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months
CBR
Time frame: Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Progression-Free Survival (PFS)
PFS
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
PK: AUC of LY3295668
Time frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of LY3295668 in Combination with Endocrine Therapy
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Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium
PK: AUC of LY3295668 in Combination with Endocrine Therapy
Time frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Endocrine Therapy in Combination with LY3295668
PK: AUC of Endocrine Therapy in Combination with LY3295668
Time frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Midazolam
PK: AUC of Midazolam
Time frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Midazolam in Combination with LY3295668
PK: AUC of Midazolam in Combination with LY3295668
Time frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)