A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer (neoMONARCH)

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Early-Stage Breast Carcinoma; Hormone Receptor Positive Tumor
• Intervention / Treatment: Drug: Abemaciclib; Drug: Anastrozole; Drug: Loperamide

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Innsbruck, Austria, 6020
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Wien, Austria, 1090
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• Belgium
  • Edegem, Belgium, 2650
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  • Hasselt, Belgium, 3500
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  • Namur, Belgium, 5000
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  • Yvoir, Belgium, 5530
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• Canada
  • Montreal, Canada, H4A 3J1
    • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
  • Ottawa, Canada, K1H 8L6
    • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
• Germany
  • Berlin, Germany, 13125
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Erlangen, Germany, 91054
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  • Essen, Germany, 45136
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Esslingen, Germany, 73730
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  • Freiburg, Germany, 79106
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  • Furth, Germany, 90766
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  • Heidelberg, Germany, 69120
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  • Ludwigsburg, Germany, 71640
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  • Tubingen, Germany, 72076
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  • Ulm, Germany, 89075
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• Italy
  • Milano, Italy, 20141
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Napoli, Italy, 80131
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  • Padova, Italy, 35128
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  • Piacenza, Italy, 29121
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• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Gangnam-gu, Korea, Republic of, 06351
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Seodaemun-gu, Korea, Republic of, 03722
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • Seongbuk-gu, Korea, Republic of, 02841
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  • Seongnam, Korea, Republic of, 13496
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  • Songpa-gu, Korea, Republic of, 05505
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • Ulsan-si, Korea, Republic of, 44033
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Rotterdam, Netherlands, 3015 GD
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
• Spain
  • Badajoz, Spain, 06080
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Lleida, Spain, 25198
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Madrid, Spain, 28034
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Malaga, Spain, 29010
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
• Taiwan
  • Changhua, Taiwan, 500
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Taichung, Taiwan, 40447
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
  • Taipei, Taiwan, 100
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
• United States
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood and Cancer Center
    • La Jolla, California, United States, 92037-0845
      • University of California-San Diego
    • Los Angeles, California, United States, 90024
      • UCLA Medical Center
    • Los Angeles, California, United States, 90024
      • SMO TRIO -Translational Research
    • Redondo Beach, California, United States, 90277
      • Cancer Care Associates Medical Group
    • Santa Barbara, California, United States, 93105
      • Sansum Medical Research Foundation
    • Santa Monica, California, United States, 93454
      • Central Coast Medical Oncology Corporation
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80203
      • SMO Pharmatech Oncology Inc
    • Grand Junction, Colorado, United States, 81501
      • St Mary's Hospital Regional Cancer Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital Inc.
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
    • Miami, Florida, United States, 33133
      • Oncology and Radiation Associates
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc
    • Plantation, Florida, United States, 33324
      • Florida Cancer Research Institute
  • Georgia
    • Athens, Georgia, United States, 30607
      • Northeast Georgia Cancer Care, LLC
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Foundation Hospitals
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 80203
      • University of Massachusetts Medical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology-Oncology
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medical College
  • Oregon
    • Bend, Oregon, United States, 97701
      • St. Charles Health System
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic
  • Texas
    • Houston, Texas, United States, 77090
      • Millennium Oncology
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
  • Washington
    • Kennewick, Washington, United States, 99336
      • Columbia Basin Hematology & Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Have postmenopausal status.
• Adenocarcinoma of the breast.
• Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.
• Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
• Primary breast cancer that is suitable for baseline core biopsy.
• Have adequate organ function.

Exclusion Criteria:

• Bilateral invasive breast cancer.
• Metastatic breast cancer (local spread to axillary lymph nodes is permitted).
• Inflammatory breast cancer.
• Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
• Prior radiotherapy to the ipsilateral chest wall for any malignancy.
• Prior anti-estrogen therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abemaciclib + Anastrozole; Abemaciclib (150 milligrams [mg]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.	Drug: Abemaciclib; Administered orally; Other Names: LY2835219; Drug: Anastrozole; Administered orally; Drug: Loperamide; Administered orally
Experimental: Abemaciclib; Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.	Drug: Abemaciclib; Administered orally; Other Names: LY2835219; Drug: Anastrozole; Administered orally; Drug: Loperamide; Administered orally
Active Comparator: Anastrozole; Anastrozole (1 mg) is given orally QD for 2 weeks. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.	Drug: Abemaciclib; Administered orally; Other Names: LY2835219; Drug: Anastrozole; Administered orally; Drug: Loperamide; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline to 2 Weeks in Ki67 Expression	Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.	Baseline, 2 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Pathologic Complete Response (pCR)	pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.	From Start of Treatment Up to 16 Weeks
Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response	Clinical objective response is defined as the percentage of participants with the best overall response rate (ORR) with a best OR of CR or PR, according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. ORR is recorded from the start of the study treatment until the earliest of objective progression or start of new anticancer therapy. A responder depends on target and non-target disease and the appearance of new lesions. CR is defined as the disappearance of all non-target lesions. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. All lymph nodes are non-pathological or normal in size (<10mm short axis). Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, a relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm.	From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)
Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response	Radiological response is the percentage of participants with CR or, PR according to RECIST v.1.1. A responder is defined as any participant who exhibits a CR or PR. CR is the disappearance of all target lesions. PR is a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD is 20% increase in the sum of diameters of target lesions taking as reference the smallest sum and the appearance of 1 or more new lesions.	From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, emotional, cognitive, or social functioning), global health status and symptom scales of fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.	Baseline, 2 Weeks
Pharmacokinetics (PK): Apparent Clearance of Abemaciclib	Abemaciclib apparent clearance (CL/F) was calculated by population nonlinear mixed effects modeling (NONMEM) using all available data spanning cycles 1 and cycles 3-5.	Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose
PK: Apparent Volume of Distribution of Abemaciclib	Abemaciclib apparent volume of distribution was calculated by population NONMEM using all available data spanning cycles 1 and cycles 3-5.	Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Franzoi MA, Lambertini M, Ceppi M, Bruzzone M, de Azambuja E. Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients. Breast Cancer Res Treat. 2022 Apr;192(2):457-462. doi: 10.1007/s10549-022-06525-3. Epub 2022 Jan 25.
• Hurvitz SA, Martin M, Press MF, Chan D, Fernandez-Abad M, Petru E, Rostorfer R, Guarneri V, Huang CS, Barriga S, Wijayawardana S, Brahmachary M, Ebert PJ, Hossain A, Liu J, Abel A, Aggarwal A, Jansen VM, Slamon DJ. Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR+/HER2- Breast Cancer. Clin Cancer Res. 2020 Feb 1;26(3):566-580. doi: 10.1158/1078-0432.CCR-19-1425. Epub 2019 Oct 15.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 16, 2016
• Study Completion (Actual): February 12, 2018

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: cyclin-dependent kinase (CDK) 4/6 inhibitor; CDK 4 and 6 inhibitor
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole; Loperamide; Antidiarrheals
• Other Study ID Numbers: 15805; I3Y-MC-JPBY (Other Identifier: Eli Lilly and Company); 2014-005486-75 (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 European Union (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