Active not recruiting

A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer (monarchE)

I3Y-MC-JPCF - ClinicalTrials.gov - NCT03155997

The purpose of this study is to test whether the combination of the study drug abemaciclib plus adjuvant endocrine therapy improves outcomes in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer compared to adjuvant endocrine therapy alone.
How long will I be in the trial?
Your study participation is expected to be approximately 10 years
Email
Active not recruiting

A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer (monarchE)

I3Y-MC-JPCF - ClinicalTrials.gov - NCT03155997

The purpose of this study is to test whether the combination of the study drug abemaciclib plus adjuvant endocrine therapy improves outcomes in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer compared to adjuvant endocrine therapy alone.
How long will I be in the trial?
Your study participation is expected to be approximately 10 years
Email

Key Requirements

Age :

18+

Sex:

All

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

All

Participants must

Participant must have confirmed hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-) breast cancer

Participant must have received surgery for this breast cancer

Participant must start study treatment within 12 weeks of completing their last non-endocrine treatment

Female participant of child-bearing potential must have a negative serum pregnancy test and agree to use highly effective birth control methods

Participants must NOT

Female participant must not be pregnant or breastfeeding

Participant must be able to swallow oral medications

Participant must not have metastatic or lymph node negative disease

Participant must not have previously received treatment with any CDK4 and CDK6 inhibitor

Participant must start study treatment within 12 weeks of completing their last non-endocrine treatment

Participant must not have received an experimental treatment in a clinical trial within the last 30 days

Trial Summary

Conditions the trial is for

Breast Cancer

What the trial is testing?

Abemaciclib, Standard Adjuvant Endocrine Therapy

Could I receive a Placebo?

no

Enrollment Goal

4580

Trial Dates

July 2017 - June 2029

Trial Phase

3

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

All

Participants must

Participant must have confirmed hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-) breast cancer

Participant must have received surgery for this breast cancer

Participant must start study treatment within 12 weeks of completing their last non-endocrine treatment

Female participant of child-bearing potential must have a negative serum pregnancy test and agree to use highly effective birth control methods

Participants must NOT

Female participant must not be pregnant or breastfeeding

Participant must be able to swallow oral medications

Participant must not have metastatic or lymph node negative disease

Participant must not have previously received treatment with any CDK4 and CDK6 inhibitor

Participant must start study treatment within 12 weeks of completing their last non-endocrine treatment

Participant must not have received an experimental treatment in a clinical trial within the last 30 days

Trial Summary

Conditions the trial is for

Breast Cancer

What the trial is testing?

Abemaciclib, Standard Adjuvant Endocrine Therapy

Could I receive a Placebo?

no

Enrollment Goal

4580

Trial Dates

July 2017 - June 2029

Trial Phase

3

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Trial Locations

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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?