I3Y-MC-JPCG - ClinicalTrials.gov - NCT02747004
I3Y-MC-JPCG - ClinicalTrials.gov - NCT02747004
Key Requirements
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.
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
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.
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
Trial Locations
Hide locations not currently recruiting