I3Y-MC-JPBH - ClinicalTrials.gov - NCT02057133
I3Y-MC-JPBH - ClinicalTrials.gov - NCT02057133
Key Requirements
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Participants must
Participant in Parts A-E and G must have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer; Participant in Part F must have a diagnosis of HER2 positive metastatic breast cancer
Participant in Part A (LY2835219 + letrozole) must not have received prior systemic endocrine therapy for metastatic disease,eExcept for ongoing therapy with letrozole
Participant in Part B (LY2835219 + anastrozole) must not have received prior systemic endocrine therapy for metastatic disease, except for ongoing therapy with anastrozole
Participant in Part C (LY2835219 + tamoxifen) may have received prior systemic endocrine therapy for metastatic disease and may be receiving ongoing therapy with tamoxifen
Participant in Part D (LY2835219 + exemestane) must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with exemestane
Participant in Part E (LY2835219 + exemestane + everolimus) must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with either exemestane or exemestane + everolimus
Participant in Part F (LY2835219 + trastuzumab) must have received at least 1 chemotherapy regimen for metastatic disease and may be receiving ongoing therapy with trastuzumab
Participant in Part F must have an estimated left ventricular ejection fraction within the normal range by either echocardiogram or multigated acquisition (MUGA) scan
Participant in Part G (abemaciclib + LY3023414 + fulvestrant) may have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease
Participants must NOT
Participant in Part G must not have type 1 diabetes mellitus or a history of gestational diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained with oral therapy as documented by Hemoglobin A1c <7%
Trial Summary
Conditions the trial is for
Solid Tumor, Metastatic Breast Cancer
What the trial is testing?
LY2835219, Letrozole, Anastrozole, Tamoxifen, Exemestane, Everolimus, Trastuzumab, LY3023414, Fulvestrant
Could I receive a Placebo?
no
Enrollment Goal
198
Trial Dates
March 2014 - October 2022
Trial Phase
1
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Participants must
Participant in Parts A-E and G must have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer; Participant in Part F must have a diagnosis of HER2 positive metastatic breast cancer
Participant in Part A (LY2835219 + letrozole) must not have received prior systemic endocrine therapy for metastatic disease,eExcept for ongoing therapy with letrozole
Participant in Part B (LY2835219 + anastrozole) must not have received prior systemic endocrine therapy for metastatic disease, except for ongoing therapy with anastrozole
Participant in Part C (LY2835219 + tamoxifen) may have received prior systemic endocrine therapy for metastatic disease and may be receiving ongoing therapy with tamoxifen
Participant in Part D (LY2835219 + exemestane) must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with exemestane
Participant in Part E (LY2835219 + exemestane + everolimus) must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with either exemestane or exemestane + everolimus
Participant in Part F (LY2835219 + trastuzumab) must have received at least 1 chemotherapy regimen for metastatic disease and may be receiving ongoing therapy with trastuzumab
Participant in Part F must have an estimated left ventricular ejection fraction within the normal range by either echocardiogram or multigated acquisition (MUGA) scan
Participant in Part G (abemaciclib + LY3023414 + fulvestrant) may have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease
Participants must NOT
Participant in Part G must not have type 1 diabetes mellitus or a history of gestational diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained with oral therapy as documented by Hemoglobin A1c <7%
Trial Summary
Conditions the trial is for
Solid Tumor, Metastatic Breast Cancer
What the trial is testing?
LY2835219, Letrozole, Anastrozole, Tamoxifen, Exemestane, Everolimus, Trastuzumab, LY3023414, Fulvestrant
Could I receive a Placebo?
no
Enrollment Goal
198
Trial Dates
March 2014 - October 2022
Trial Phase
1
Trial Locations
Hide locations not currently recruiting