Recruiting

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)

I3Y-MC-JPEF - ClinicalTrials.gov - NCT05169567

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy.
How long will I be in the trial?
Your participation could last up to 5 years, depending on how you and your tumor respond.
Email
Recruiting

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)

I3Y-MC-JPEF - ClinicalTrials.gov - NCT05169567

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy.
How long will I be in the trial?
Your participation could last up to 5 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 HR+, HER2- breast cancer

Participants must have breast cancer that is advanced or has spread to another part of the body

Participants must have already received endocrine therapy and a CDK4/6 inhibitor

Participants must have adequate organ function

Participants must be in fair to good health

Participants must be able to swallow capsules/tablets

Participants must NOT

Participants must not have received chemotherapy or some targeted therapies for advanced breast cancer

Participants must not have cancer that has spread to the brain that has not been treated or is causing symptoms

Participants must not have another serious medical condition

Trial Summary

Conditions the trial is for

Metastatic Breast Cancer

What the trial is testing?

Abemaciclib, Fulvestrant, LY2835219

Could I receive a Placebo?

yes

Enrollment Goal

350

Trial Dates

March 2022 - February 2026

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 HR+, HER2- breast cancer

Participants must have breast cancer that is advanced or has spread to another part of the body

Participants must have already received endocrine therapy and a CDK4/6 inhibitor

Participants must have adequate organ function

Participants must be in fair to good health

Participants must be able to swallow capsules/tablets

Participants must NOT

Participants must not have received chemotherapy or some targeted therapies for advanced breast cancer

Participants must not have cancer that has spread to the brain that has not been treated or is causing symptoms

Participants must not have another serious medical condition

Trial Summary

Conditions the trial is for

Metastatic Breast Cancer

What the trial is testing?

Abemaciclib, Fulvestrant, LY2835219

Could I receive a Placebo?

yes

Enrollment Goal

350

Trial Dates

March 2022 - February 2026

Trial Phase

3

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Trial Locations

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Metastatic Breast Cancer Resources

Understanding Cancer Clinical Trials

Here are some answers to some common questions about cancer trials to consider as you or your loved one determine whether or not a clinical trial is a good fit for you.
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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?