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

Primary Purpose

Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Abemaciclib

Loperamide

Anastrozole

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring cyclin-dependent kinase (CDK) 4/6 inhibitor, CDK 4 and 6 inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Comprehensive Blood and Cancer Center
University of California-San Diego
SMO TRIO -Translational Research
UCLA Medical Center
Cancer Care Associates Medical Group
Sansum Medical Research Foundation
Central Coast Medical Oncology Corporation
Stanford University
SMO Pharmatech Oncology Inc
St Mary's Hospital Regional Cancer Center
Holy Cross Hospital Inc.
Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
Oncology and Radiation Associates
Orlando Health, Inc
Florida Cancer Research Institute
Northeast Georgia Cancer Care, LLC
Georgia Regents University
Kaiser Foundation Hospitals
Walter Reed National Military Medical Center
University of Massachusetts Medical Center
Nebraska Hematology-Oncology
Weill Cornell Medical College
St. Charles Health System
The West Clinic
Millennium Oncology
Utah Cancer Specialists
Columbia Basin Hematology & Oncology
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Abemaciclib + Anastrozole

Abemaciclib

Anastrozole

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With Pathologic Complete Response (pCR)

pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02441946

First Posted

May 8, 2015

Last Updated

June 10, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02441946

Brief Title

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

Acronym

neoMONARCH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

August 16, 2016 (Actual)

Study Completion Date

February 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abemaciclib + Anastrozole

Arm Type

Experimental

Arm Description

Arm Title

Abemaciclib

Arm Type

Experimental

Arm Description

Arm Title

Anastrozole

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Abemaciclib

Other Intervention Name(s)

LY2835219

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Loperamide

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Anastrozole

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Percent Change From Baseline to 2 Weeks in Ki67 Expression

Description

Time Frame

Baseline, 2 Weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With Pathologic Complete Response (pCR)

Description

pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.

Time Frame

From Start of Treatment Up to 16 Weeks

Title

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

Description

Time Frame

From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)

Title

Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response

Description

Time Frame

From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)

Title

Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Description

Time Frame

Baseline, 2 Weeks

Title

Pharmacokinetics (PK): Apparent Clearance of Abemaciclib

Description

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.

Time Frame

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

Title

PK: Apparent Volume of Distribution of Abemaciclib

Description

Abemaciclib apparent volume of distribution was calculated by population NONMEM using all available data spanning cycles 1 and cycles 3-5.

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Comprehensive Blood and Cancer Center

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

University of California-San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037-0845

Country

United States

Facility Name

SMO TRIO -Translational Research

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

Cancer Care Associates Medical Group

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Sansum Medical Research Foundation

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

Central Coast Medical Oncology Corporation

City

Santa Monica

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

SMO Pharmatech Oncology Inc

City

Denver

State/Province

Colorado

ZIP/Postal Code

80203

Country

United States

Facility Name

St Mary's Hospital Regional Cancer Center

City

Grand Junction

State/Province

Colorado

ZIP/Postal Code

81501

Country

United States

Facility Name

Holy Cross Hospital Inc.

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Memorial Regional Hospital/Joe Dimaggio Childrens Hospital

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Oncology and Radiation Associates

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Orlando Health, Inc

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Florida Cancer Research Institute

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Northeast Georgia Cancer Care, LLC

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Georgia Regents University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Kaiser Foundation Hospitals

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96819

Country

United States

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889

Country

United States

Facility Name

University of Massachusetts Medical Center

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

80203

Country

United States

Facility Name

Nebraska Hematology-Oncology

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

St. Charles Health System

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Facility Name

The West Clinic

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Millennium Oncology

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Utah Cancer Specialists

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Columbia Basin Hematology & Oncology

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

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.

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

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.

City

Montreal

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

City

Ottawa

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

City

Esslingen

ZIP/Postal Code

73730

Country

Germany

Facility Name

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

City

Furth

ZIP/Postal Code

90766

Country

Germany

Facility Name

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Facility Name

City

Tubingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

City

Piacenza

ZIP/Postal Code

29121

Country

Italy

Facility Name

City

Daegu

ZIP/Postal Code

41404

Country

Korea, Republic of

Facility Name

City

Gangnam-gu

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

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

City

Seodaemun-gu

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

City

Seongbuk-gu

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

City

Seongnam

ZIP/Postal Code

13496

Country

Korea, Republic of

Facility Name

City

Songpa-gu

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

City

Ulsan-si

ZIP/Postal Code

44033

Country

Korea, Republic of

Facility Name

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

City

Badajoz

ZIP/Postal Code

06080

Country

Spain

Facility Name

City

Lleida

ZIP/Postal Code

25198

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://vivli.org/

Citations:

PubMed Identifier

35076812

Citation

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.

Results Reference

derived

PubMed Identifier

31615937

Citation

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.

Results Reference

derived

Learn more about this trial

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

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