Not yet recruiting

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER)

I3Y-MC-JPCW - ClinicalTrials.gov - NCT04752332

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+).
How long will I be in the trial?
Your participation could last up to 10 years depending on how you and your tumor respond.
Email
Not yet recruiting

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER)

I3Y-MC-JPCW - ClinicalTrials.gov - NCT04752332

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+).
How long will I be in the trial?
Your participation could last up to 10 years depending on how you and your tumor respond.
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

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

Participants must have had surgery for this breast cancer

Participants must have had chemotherapy and therapy targeted for HER2+ breast cancer

Female participant of child-bearing potential must agree to use highly effective birth control methods

Participants must be able to swallow oral medications

Participants must NOT

Female participant must not be pregnant or breastfeeding

Participants must not have breast cancer that has spread to another part(s) of the body

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

Trial Summary

Conditions the trial is for

Non-Metastatic Breast Cancer

What the trial is testing?

Abemaciclib Plus Hormone Therapy

Could I receive a Placebo?

yes

Enrollment Goal

2450

Trial Dates

April 2021 - February 2033

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

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

Participants must have had surgery for this breast cancer

Participants must have had chemotherapy and therapy targeted for HER2+ breast cancer

Female participant of child-bearing potential must agree to use highly effective birth control methods

Participants must be able to swallow oral medications

Participants must NOT

Female participant must not be pregnant or breastfeeding

Participants must not have breast cancer that has spread to another part(s) of the body

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

Trial Summary

Conditions the trial is for

Non-Metastatic Breast Cancer

What the trial is testing?

Abemaciclib Plus Hormone Therapy

Could I receive a Placebo?

yes

Enrollment Goal

2450

Trial Dates

April 2021 - February 2033

Trial Phase

3

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Trial Locations

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Non-Metastatic 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?