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.
Email
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.
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- 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

Not the right fit? Sign up to receive updates on new trials.

Trial Locations

Hide locations not currently recruiting

Enter your postal code to see sites near you

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?