Active not recruiting
A Study of Abemaciclib (LY2835219) in Combination With Other Therapies in Participants With Breast Cancer That Has Spread
I3Y-MC-JPBH - ClinicalTrials.gov - NCT02057133
This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide, or ongoing endocrine therapy) for breast cancer that has spread to other parts of the body.
How long will I be in the trial?
Your participation could last up to 4 years depending on how you and your tumor respond.
Active not recruiting
A Study of Abemaciclib (LY2835219) in Combination With Other Therapies in Participants With Breast Cancer That Has Spread
I3Y-MC-JPBH - ClinicalTrials.gov - NCT02057133
This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide, or ongoing endocrine therapy) for breast cancer that has spread to other parts of the body.
How long will I be in the trial?
Your participation could last up to 4 years depending on how you and your tumor respond.
Key Requirements
Age :
18+
Sex:
Female
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.
Age
18+
Sex
Female
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
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
Enter your postal code to find the nearest site
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.
Age
18+
Sex
Female
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
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
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Trial Locations
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