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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031885
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Abemaciclib Drug: Fulvestrant Drug: Standard Chemotherapy Phase 4

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Abemaciclib + Fulvestrant
Abemaciclib given orally and fulvestrant given by intramuscular (IM) injection.
 Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Drug: Fulvestrant
Administered IM
Active Comparator: Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label.
 Drug: Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    ORR


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 31 Months) ]
    PFS

  2. Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 31 Months) ]
    TTR

  3. 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) ]
    DoR

  4. PFS 2 [ Time Frame: Baseline to Second Objective Progression or Death Due to Any Cause (Estimated up to 62 Months) ]
    PFS 2


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031885


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer  This link exits the ClinicalTrials.gov site

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04031885    
Other Study ID Numbers: 17320
I3Y-MC-JPCU ( Other Identifier: Eli Lilly and Company )
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs