Active not recruiting
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1)
I3Y-MC-JPCG - ClinicalTrials.gov - NCT02747004
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
How long will I be in the trial?
The duration of your participation depends on how well your disease responds to the study treatment.
Active not recruiting
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1)
I3Y-MC-JPCG - ClinicalTrials.gov - NCT02747004
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
How long will I be in the trial?
The duration of your participation depends on how well your disease responds to the study treatment.
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- breast cancer
Participant must have relapsed or progressed following endocrine therapy
Participant must have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting
Participant must have a negative serum pregnancy test within 7 days prior to randomization and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment
Participant must be able to swallow oral medication
Participants must NOT
Participant must not have active bacterial or fungal infection, or detectable viral infection
Participant must not have received treatment with a prior cyclin-dependent kinase 4 (CDK4) and CDK 6 inhibitor
Participant must not have a preexisting chronic condition resulting in persistent diarrhea
Participant must not have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years
Trial Summary
Conditions the trial is for
Metastatic Breast Cancer, Solid Tumor
What the trial is testing?
Abemaciclib, Abemaciclib + Tamoxifen, Abemaciclib + Prophylactic Loperamide
Could I receive a Placebo?
no
Enrollment Goal
225
Trial Dates
September 2016 - August 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- breast cancer
Participant must have relapsed or progressed following endocrine therapy
Participant must have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting
Participant must have a negative serum pregnancy test within 7 days prior to randomization and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment
Participant must be able to swallow oral medication
Participants must NOT
Participant must not have active bacterial or fungal infection, or detectable viral infection
Participant must not have received treatment with a prior cyclin-dependent kinase 4 (CDK4) and CDK 6 inhibitor
Participant must not have a preexisting chronic condition resulting in persistent diarrhea
Participant must not have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years
Trial Summary
Conditions the trial is for
Metastatic Breast Cancer, Solid Tumor
What the trial is testing?
Abemaciclib, Abemaciclib + Tamoxifen, Abemaciclib + Prophylactic Loperamide
Could I receive a Placebo?
no
Enrollment Goal
225
Trial Dates
September 2016 - August 2021
Trial Phase
2
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Trial Locations
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