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
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
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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