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.
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.
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, 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 2022
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, 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 2022
Trial Phase
2
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Trial Locations
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