Clinical Trials /

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

NCT04031885

Description:

The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
  • Official Title: A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases

Clinical Trial IDs

  • ORG STUDY ID: 17320
  • SECONDARY ID: I3Y-MC-JPCU
  • NCT ID: NCT04031885

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
AbemaciclibLY2835219Abemaciclib + Fulvestrant
FulvestrantAbemaciclib + Fulvestrant
Standard ChemotherapyStandard Chemotherapy

Purpose

The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.

Trial Arms

NameTypeDescriptionInterventions
Abemaciclib + FulvestrantExperimentalAbemaciclib given orally and fulvestrant given by intramuscular (IM) injection.
  • Abemaciclib
  • Fulvestrant
Standard ChemotherapyActive ComparatorStandard chemotherapy of physician's choice administered according to product label.
  • Standard Chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must be females of post-menopausal status with HR+, HER2- breast cancer
             that has spread to internal organs

          -  Participants must have had at least one endocrine therapy

          -  Participants must be willing to use a device to answer daily questions about how they
             are doing for the duration of their participation in the study

          -  If participant has diarrhea from a previous treatment, they should talk to their
             doctor to ensure they have recovered enough to participate in this study

        Exclusion Criteria:

          -  Participants must not have breast cancer that has spread to the brain if untreated and
             with symptoms

          -  Participants must not have had any systemic treatment after their breast cancer has
             spread unless it is endocrine therapy

          -  Participants must not have certain active infections including HIV or hepatitis

          -  Participants must not be pregnant or breastfeeding

          -  Participants must not have certain types of cancers or certain previous cancer
             treatments

          -  Participants must not have certain serious medical conditions, including heart or lung
             disease, or have had certain types of tissue or organ transplants
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Time Frame:Baseline through Measured Progressive Disease (Estimated up to 31 Months)
Safety Issue:
Description:ORR

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 31 Months)
Safety Issue:
Description:PFS
Measure:Time to Response (TTR)
Time Frame:Baseline to Date of CR or PR (Estimated up to 31 Months)
Safety Issue:
Description:TTR
Measure:Duration of Response (DoR)
Time Frame:Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 31 Months)
Safety Issue:
Description:DoR
Measure:PFS 2
Time Frame:Baseline to Second Objective Progression or Death Due to Any Cause (Estimated up to 62 Months)
Safety Issue:
Description:PFS 2

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

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