NCT02441946

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Aug 2015

Geographic Reach
10 countries

66 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 30, 2018

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

May 8, 2015

Results QC Date

October 27, 2017

Last Update Submit

June 10, 2020

Conditions

Breast CancerHormone Receptor Positive TumorEarly-Stage Breast Carcinoma

Keywords

cyclin-dependent kinase (CDK) 4/6 inhibitorCDK 4 and 6 inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Percentage of Participants With Pathologic Complete Response (pCR)

    From Start of Treatment Up to 16 Weeks

  • Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response

    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

    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)

    Baseline, 2 Weeks

  • Pharmacokinetics (PK): Apparent Clearance of Abemaciclib

    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

  • +1 more secondary outcomes

Study Arms (3)

Abemaciclib + Anastrozole

EXPERIMENTAL

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: AbemaciclibDrug: LoperamideDrug: Anastrozole

Abemaciclib

EXPERIMENTAL

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: AbemaciclibDrug: LoperamideDrug: Anastrozole

Anastrozole

ACTIVE COMPARATOR

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: AbemaciclibDrug: LoperamideDrug: Anastrozole

Interventions

AbemaciclibDRUG

Administered orally

Also known as: LY2835219
AbemaciclibAbemaciclib + AnastrozoleAnastrozole
LoperamideDRUG

Administered orally

AbemaciclibAbemaciclib + AnastrozoleAnastrozole
AnastrozoleDRUG

Administered orally

AbemaciclibAbemaciclib + AnastrozoleAnastrozole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (66)

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

University of California-San Diego

La Jolla, California, 92037-0845, United States

Location

SMO TRIO -Translational Research

Los Angeles, California, 90024, United States

Location

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

Cancer Care Associates Medical Group

Redondo Beach, California, 90277, United States

Location

Sansum Medical Research Foundation

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Monica, California, 93454, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

SMO Pharmatech Oncology Inc

Denver, Colorado, 80203, United States

Location

St Mary's Hospital Regional Cancer Center

Grand Junction, Colorado, 81501, United States

Location

Holy Cross Hospital Inc.

Fort Lauderdale, Florida, 33308, United States

Location

Memorial Regional Hospital/Joe Dimaggio Childrens Hospital

Hollywood, Florida, 33021, United States

Location

Oncology and Radiation Associates

Miami, Florida, 33133, United States

Location

Orlando Health, Inc

Orlando, Florida, 32806, United States

Location

Florida Cancer Research Institute

Plantation, Florida, 33324, United States

Location

Northeast Georgia Cancer Care, LLC

Athens, Georgia, 30607, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Kaiser Foundation Hospitals

Honolulu, Hawaii, 96819, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 80203, United States

Location

Nebraska Hematology-Oncology

Lincoln, Nebraska, 68506, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

St. Charles Health System

Bend, Oregon, 97701, United States

Location

The West Clinic

Germantown, Tennessee, 38138, United States

Location

Millennium Oncology

Houston, Texas, 77090, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

Columbia Basin Hematology & Oncology

Kennewick, Washington, 99336, United States

Location

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.

Graz, 8036, Austria

Location

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Innsbruck, 6020, Austria

Location

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Vienna, 1090, Austria

Location

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Edegem, 2650, Belgium

Location

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Hasselt, 3500, Belgium

Location

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Namur, 5000, Belgium

Location

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Yvoir, 5530, Belgium

Location

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Montreal, H4A 3J1, Canada

Location

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Ottawa, K1H 8L6, Canada

Location

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Berlin, 13125, Germany

Location

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Erlangen, 91054, Germany

Location

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Essen, 45136, Germany

Location

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Esslingen am Neckar, 73730, Germany

Location

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Freiburg im Breisgau, 79106, Germany

Location

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Fürth, 90766, Germany

Location

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Heidelberg, 69120, Germany

Location

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Ludwigsburg, 71640, Germany

Location

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Tübingen, 72076, Germany

Location

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Ulm, 89075, Germany

Location

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Milan, 20141, Italy

Location

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Napoli, 80131, Italy

Location

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Padua, 35128, Italy

Location

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Piacenza, 29121, Italy

Location

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Maastricht, 6229 HX, Netherlands

Location

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Rotterdam, 3015 GD, Netherlands

Location

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Daegu, 41404, South Korea

Location

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Gangnam-gu, 06351, South Korea

Location

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Seodaemun-gu, 03722, South Korea

Location

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Seongbuk-gu, 02841, South Korea

Location

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Seongnam, 13496, South Korea

Location

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Songpa-gu, 05505, South Korea

Location

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Ulsan, 44033, South Korea

Location

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Badajoz, 06080, Spain

Location

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Lleida, 25198, Spain

Location

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Madrid, 28034, Spain

Location

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Málaga, 29010, Spain

Location

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Changhua, 500, Taiwan

Location

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Taichung, 40447, Taiwan

Location

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Taipei, 100, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 35076812DERIVED

  • 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.

    PMID: 31615937DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclibLoperamideAnastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNitrilesOrganic ChemicalsTriazolesAzoles

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 12, 2015

Study Start

August 1, 2015

Primary Completion

August 16, 2016

Study Completion

February 12, 2018

Last Updated

June 17, 2020

Results First Posted

January 30, 2018

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

US(27)BE(4)NL(2)KR(7)AU(3)ES(4)TW(3)CA(2)DE(10)IT(4)