Active not recruiting

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

I3Y-MC-JPBZ - ClinicalTrials.gov - NCT02675231

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with HR+, HER2+ locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
How long will I be in the trial?
The duration of your participation depends on how well your disease responds to the study treatment and how many cycles of treatment you receive.
Email
Active not recruiting

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

I3Y-MC-JPBZ - ClinicalTrials.gov - NCT02675231

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with HR+, HER2+ locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
How long will I be in the trial?
The duration of your participation depends on how well your disease responds to the study treatment and how many cycles of treatment you receive.
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 must have a diagnosis of HR+, HER2+ advanced breast cancer

Participant must have unresectable, locally advanced, recurrent breast cancer or metastatic breast cancer

Participant must provide adequate tumor tissue prior to participation

Participant must have previously received at least two HER2-directed therapies for advanced disease

Participant must have received a taxane and trastuzumab emtansine (T-DM1) in any disease setting

Participant must have received any endocrine therapy (excluding fulvestrant)

Participant must have postmenopausal status

Participants must NOT

Participant must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor

Participant must not have had symptomatic congestive heart failure, heart attack, or unstable angina within the last 6 months

Participant must not have known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms

Trial Summary

Conditions the trial is for

Metastatic Breast Cancer, Breast Cancer, Solid Tumor

What the trial is testing?

Abemaciclib (LY2835219) + Trastuzumab + Fulvestrant, Abemaciclib (LY2835219) + Trastuzumab, Standard of care chemotherapy + Trastuzumab

Could I receive a Placebo?

no

Enrollment Goal

225

Trial Dates

May 2016 - February 2021

Trial Phase

2

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 must have a diagnosis of HR+, HER2+ advanced breast cancer

Participant must have unresectable, locally advanced, recurrent breast cancer or metastatic breast cancer

Participant must provide adequate tumor tissue prior to participation

Participant must have previously received at least two HER2-directed therapies for advanced disease

Participant must have received a taxane and trastuzumab emtansine (T-DM1) in any disease setting

Participant must have received any endocrine therapy (excluding fulvestrant)

Participant must have postmenopausal status

Participants must NOT

Participant must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor

Participant must not have had symptomatic congestive heart failure, heart attack, or unstable angina within the last 6 months

Participant must not have known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms

Trial Summary

Conditions the trial is for

Metastatic Breast Cancer, Breast Cancer, Solid Tumor

What the trial is testing?

Abemaciclib (LY2835219) + Trastuzumab + Fulvestrant, Abemaciclib (LY2835219) + Trastuzumab, Standard of care chemotherapy + Trastuzumab

Could I receive a Placebo?

no

Enrollment Goal

225

Trial Dates

May 2016 - February 2021

Trial Phase

2

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Trial Locations

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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?