A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Abemaciclib

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • North Sydney, New South Wales, Australia, 2291
      • Mater Private Hospital
    • Sydney, New South Wales, Australia, 2010
      • St Vincent's Hospital
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Centre Research
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Russian Oncological Research Center
  • Volgograd, Russian Federation, 400138
    • Volgograd Regional Clinical Oncology Dispensary
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08023
    • Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28034
    • Hospital Ruber Internacional
• Turkey
  • Antalya, Turkey, 07058
    • Akdeniz University Medical Faculty
  • Edirne, Turkey, 22030
    • Trakya University Faculty of Medicine
  • Izmir, Turkey, 35575
    • Medical Park Izmir Hospital
  • Malatya, Turkey, 44280
    • Inonu University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).

• Have all of the following:

  • Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
  • Prior treatment with chemotherapy for locally advanced or metastatic disease.
  • No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
• Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
• Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
• Have adequate organ function.
• Women of child-bearing potential must have a negative pregnancy test.
• Are able to swallow tablets/capsules.

Exclusion Criteria:

• Are currently receiving treatment in a clinical study involving an investigational product.
• Have a serious concomitant systemic disorder.
• Have symptomatic central nervous system (CNS) malignancy or metastasis.
• Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
• Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
• Have a history of any other cancer.
• Had major surgery within 14 days prior to randomization.
• Are breastfeeding.
• Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200 mg Abemaciclib With a Meal; 200 mg abemaciclib given twice a day (BID) orally with a meal.	Drug: Abemaciclib; Administered orally.; Other Names: LY2835219
Experimental: 200 mg Abemaciclib Without a Meal; 200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.	Drug: Abemaciclib; Administered orally.; Other Names: LY2835219
Experimental: 200 mg Abemaciclib Without Regard to Food; 200 mg abemaciclib given twice a day (BID) orally without regard for food.	Drug: Abemaciclib; Administered orally.; Other Names: LY2835219

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Severe Diarrhea (≥ Grade 3)	Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).	Cycle 3 (28 Days Cycle)
Percentage of Participants With Prolonged Grade 2 Diarrhea	Percentage of participants with prolonged grade 2 diarrhea during first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Prolonged Grade 2 diarrhea was any event lasting more than 7 days. Grade 2 was defined as Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline.	Cycle 3 (28 Days Cycle)
Percentage of Participants With Dose Reductions Due to Diarrhea	Percentage of participants with dose reductions due to diarrhea during first 3 cycles.	Cycle 3 (28 Days Cycle)
Percentage of Participants With Dose Interruptions Due to Diarrhea	Percentage of participants with dose interruptions due to diarrhea during first 3 cycles.	Cycle 3 (28 Days Cycle)
Percentage of Participants Who Discontinue Treatment Due to Diarrhea	Percentage of participants who discontinue treatment due to diarrhea	Cycle 3 (28 Days Cycle)
Percentage of Participants Utilizing Antidiarrheals	Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.	Cycle 3 (28 Days Cycle)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib	PK: Mean steady state exposure of abemaciclib	Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567	PK: Mean steady state exposure of abemaciclib metabolite LSN2839567	Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726	PK: Mean steady state exposure of abemaciclib metabolite LSN3106726	Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Publications and helpful links

Helpful Links

• A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): July 29, 2019
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 17041; I3Y-MC-JPCP (Other Identifier: Eli Lilly and Company); 2018-001853-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No