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.
Email
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.
Email

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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Breast Cancer Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?