Suspended

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

I3Y-MC-JPCU - ClinicalTrials.gov - NCT04031885

The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastaticbreast cancer that has spread to internal organs.
How long will I be in the trial?
Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.
Email
Suspended

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

I3Y-MC-JPCU - ClinicalTrials.gov - NCT04031885

The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastaticbreast cancer that has spread to internal organs.
How long will I be in the trial?
Your participation in this trial could last up to 31 months, depending on your cancer type and 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

Participants must be females of post-menopausal status with HR+, HER2- breast cancer that has spread to internal organs

Participants must have had at least one endocrine therapy

Participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study

If participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study

Participants must NOT

Participants must not have breast cancer that has spread to the brain if untreated and with symptoms

Participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy

Participants must not have certain active infections including HIV or hepatitis

Participants must not be pregnant or breastfeeding

Participants must not have certain types of cancers or certain previous cancer treatments

Participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants

Trial Summary

Conditions the trial is for

Metastatic Breast Cancer

What the trial is testing?

Abemaciclib, Fulvestrant, Standard Chemotherapy

Could I receive a Placebo?

no

Enrollment Goal

300

Trial Dates

August 2019 - December 2022

Trial Phase

4

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

Participants must be females of post-menopausal status with HR+, HER2- breast cancer that has spread to internal organs

Participants must have had at least one endocrine therapy

Participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study

If participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study

Participants must NOT

Participants must not have breast cancer that has spread to the brain if untreated and with symptoms

Participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy

Participants must not have certain active infections including HIV or hepatitis

Participants must not be pregnant or breastfeeding

Participants must not have certain types of cancers or certain previous cancer treatments

Participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants

Trial Summary

Conditions the trial is for

Metastatic Breast Cancer

What the trial is testing?

Abemaciclib, Fulvestrant, Standard Chemotherapy

Could I receive a Placebo?

no

Enrollment Goal

300

Trial Dates

August 2019 - December 2022

Trial Phase

4

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Trial Locations

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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?