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:

Terminated

Phase:

Phase 4

URL:

https://clinicaltrials.gov/show/NCT04031885

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 ChemotherapyCapecitabine, Docetaxel, Nab paclitaxel, PaclitaxelStandard 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 + FulvestrantExperimental150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.
  • Abemaciclib
  • Fulvestrant
Standard ChemotherapyActive ComparatorStandard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), 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:Randomization to Measured Progressive Disease (Up to 12 Months)
Safety Issue:
Description:ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to the corresponding treatment arm [intent-to-treat (ITT) population], based on investigator-assessed tumor responses.CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking in reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Confirmations of CR and PR are not required.

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months)
Safety Issue:
Description:PFS is defined as the time from first dose date until the first occurrence of documented disease progression per Response Criteria In Solid Tumors version 1.1(RECIST v1.1) or death from any cause in the absence of progressive disease. Progression-free survival will be based on investigator-assessed tumor responses; there will not be an independent central review of imaging data.
Measure:Time to Response (TTR)
Time Frame:First Dose to Date of CR or PR (Up to 12 Months)
Safety Issue:
Description:TTR is defined as the time from first dose date until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measure:Duration of Response (DoR)
Time Frame:Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months)
Safety Issue:
Description:DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or documented disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence.
Measure:Progression Free Survival 2 (PFS 2)
Time Frame:Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months)
Safety Issue:
Description:PFS 2 is defined as the time from first dose date to the disease progression date on next line (first line of post-discontinuation treatment), or starting date of the second line of post-discontinuation treatment or death from any cause, whichever is earlier, or death from any cause, whichever is earlier.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Eli Lilly and Company

Last Updated

August 24, 2021