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A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

Primary Purpose

Hormone Receptor Positive Breast Cancer, HER-2 Positive Breast Cancer

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Abemaciclib

Trastuzumab

Fulvestrant

Standard of Care Single Agent Chemotherapy

About this trial

This is an interventional treatment trial for Hormone Receptor Positive Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

diagnosis of HR+, HER2+ breast cancer (BC)
unresectable locally advanced recurrent BC or metastatic BC
adequate tumor tissue available prior to randomization
measurable and/or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
previously received:
- at least 2 HER2-directed therapies for advanced disease
- participant must have received trastuzumab emtansine (T-DM1) in any disease setting
must have received a taxane in any disease setting
may have received any endocrine therapy (excluding fulvestrant)
have postmenopausal status due to surgical / natural menopause or chemical ovarian suppression
performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale
left ventricular ejection fraction (LVEF) of 50% or higher at baseline
adequate organ function
negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if menopause induced by gonadotropin-releasing hormone (GnRH) agonist or radiation
discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy
discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy), except trastuzumab, for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy
are able to swallow capsules

Exclusion Criteria:

have visceral crisis
known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms
had major surgery within 14 days prior to randomization
received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor
received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
history within the last 6 months of symptomatic congestive heart failure, myocardial infarction, or unstable angina
history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
active bacterial, fungal infection, or detectable viral infection
have received any recent (within 28 days prior to randomization) live virus vaccination
hypersensitivity to trastuzumab, murine proteins, fulvestrant, or to any of the excipients

Sites / Locations

Comprehensive Blood and Cancer Center
St Jude Medical Center
TRIO - Translational Research in Oncology-US, Inc.
USC Norris Cancer Hospital
UCLA Medical Center
Cancer Care Associates Medical Group
Central Coast Medical Oncology Corporation
Catholic Health Initiatives (CHI)
Florida Cancer Specialists
Florida Cancer Specialists
MD Anderson Cancer Center Orlando
University of Miami Plantation
Florida Cancer Specialists
Winship Cancer Center Emory University
Northside Hospital Cancer Institute
Fort Wayne Medical Oncology & Hematology, Inc.
St Joseph Cancer Center
Dana Farber Cancer Institute
Mayo Clinic
Mayo Clinic
Billings Clinic Research Center
Brookdale Hospital Medical Center
North Shore Hematology Oncology Associates
Clinical Research Alliance, Inc
Memorial Sloan Kettering Cancer Center
University of Pennsylvania Hospital
Sarah Cannon Cancer Center
Tennessee Oncology PLLC
The Center for Cancer and Blood Disorders
Northwest Medical Specialties, PLLC
Swedish Medical Center
Seattle Cancer Care Alliance
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Universitair Ziekenhuis Leuven - Gasthuisberg
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Instituto COI de Pesquisa Educação e Gestão
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Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant

150 mg Abemaciclib + 8 mg/kg Trastuzumab

8 mg/kg Trastuzumab + Standard of Care Chemotherapy

Arm Description

150 milligram (mg) abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 milligram per kilogram (mg/kg) trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.

150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.

8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS time was measured from the date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

Secondary Outcome Measures

Overall Survival (OS)

OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

Duration of Response (DoR)

DoR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.

Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.

Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months: Clinical Benefit Rate (CBR)

Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.

Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours and typical completion time for this instrument is less than 5 minutes. Mean Interference Score data is reported here. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.

Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and 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. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.

Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status.LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.

Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)

European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.

Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20)

Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20) was evaluated. M2 and M20 are 2 major active metabolites of abemaciclib.

Full Information

NCT ID

NCT02675231

First Posted

February 3, 2016

Last Updated

September 11, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02675231

Brief Title

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

Acronym

monarcHER

Official Title

monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 23, 2016 (Actual)

Primary Completion Date

April 8, 2019 (Actual)

Study Completion Date

December 31, 2024 (Anticipated)

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 effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

6. Conditions and Keywords

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

Hormone Receptor Positive Breast Cancer, HER-2 Positive Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

237 (Actual)

8. Arms, Groups, and Interventions

Arm Title

150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant

Arm Type

Experimental

Arm Description

Arm Title

150 mg Abemaciclib + 8 mg/kg Trastuzumab

Arm Type

Experimental

Arm Description

150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.

Arm Title

8 mg/kg Trastuzumab + Standard of Care Chemotherapy

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)

Trastuzumab

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Fulvestrant

Intervention Description

Administered IM

Intervention Type

Drug

Intervention Name(s)

Standard of Care Single Agent Chemotherapy

Intervention Description

Standard-of-care single-agent chemotherapy of physician's choice administered according to product label

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Baseline to Progressive Disease or Death from Any Cause (Up To 36 Months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Baseline to Death from Any Cause (Estimated up to 48 Months)

Title

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

Description

Time Frame

Baseline to Objective Disease Progression (Up To 36 Months)

Title

Duration of Response (DoR)

Description

Time Frame

Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up To 36 Months)

Title

Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)

Description

Time Frame

Baseline to Objective Disease Progression (Up To 36 Months)

Title

Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months: Clinical Benefit Rate (CBR)

Description

Time Frame

Date of CR, PR or SD to 6 Months Post CR, PR or SD (Up To 36 Months)

Title

Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

Description

Time Frame

Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)

Title

Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

Description

Time Frame

Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)

Title

Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

Description

Time Frame

Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)

Title

Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)

Description

Time Frame

Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)

Title

Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20)

Description

Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20) was evaluated. M2 and M20 are 2 major active metabolites of abemaciclib.

Time Frame

Cycle(C)1 Day(D)1,C1D15, C2D1, C2D8, C3D1,C3D15, C4D1, C5D1:pre-dose; C1D1, C2D1, C3D1, C4D1, C5D1:post-dose

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of HR+, HER2+ breast cancer (BC) unresectable locally advanced recurrent BC or metastatic BC adequate tumor tissue available prior to randomization measurable and/or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 previously received: at least 2 HER2-directed therapies for advanced disease participant must have received trastuzumab emtansine (T-DM1) in any disease setting must have received a taxane in any disease setting may have received any endocrine therapy (excluding fulvestrant) have postmenopausal status due to surgical / natural menopause or chemical ovarian suppression performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale left ventricular ejection fraction (LVEF) of 50% or higher at baseline adequate organ function negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if menopause induced by gonadotropin-releasing hormone (GnRH) agonist or radiation discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy), except trastuzumab, for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy are able to swallow capsules Exclusion Criteria: have visceral crisis known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms had major surgery within 14 days prior to randomization received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study history within the last 6 months of symptomatic congestive heart failure, myocardial infarction, or unstable angina history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years active bacterial, fungal infection, or detectable viral infection have received any recent (within 28 days prior to randomization) live virus vaccination hypersensitivity to trastuzumab, murine proteins, fulvestrant, or to any of the excipients

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

St Jude Medical Center

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

TRIO - Translational Research in Oncology-US, Inc.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

USC Norris Cancer Hospital

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

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

Central Coast Medical Oncology Corporation

City

Santa Monica

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Catholic Health Initiatives (CHI)

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33908

Country

United States

Facility Name

MD Anderson Cancer Center Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

University of Miami Plantation

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Winship Cancer Center Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Northside Hospital Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Fort Wayne Medical Oncology & Hematology, Inc.

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

St Joseph Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55902

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Billings Clinic Research Center

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Brookdale Hospital Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11212

Country

United States

Facility Name

North Shore Hematology Oncology Associates

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733

Country

United States

Facility Name

Clinical Research Alliance, Inc

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

University of Pennsylvania Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Sarah Cannon Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

The Center for Cancer and Blood Disorders

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Northwest Medical Specialties, PLLC

City

Puyallup

State/Province

Washington

ZIP/Postal Code

98372

Country

United States

Facility Name

Swedish Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

City

Caba

ZIP/Postal Code

1025

Country

Argentina

Facility Name

City

Cordoba

ZIP/Postal Code

X5000JHGQ

Country

Argentina

Facility Name

City

Cordoba

ZIP/Postal Code

X5000JHQ

Country

Argentina

Facility Name

City

La Rioja

ZIP/Postal Code

5300

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

City

San Miguel De Tucuman

ZIP/Postal Code

T4000IAK

Country

Argentina

Facility Name

City

Viedma

ZIP/Postal Code

8500

Country

Argentina

Facility Name

City

Kurralta Park

ZIP/Postal Code

5037

Country

Australia

Facility Name

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

St. Leonards

ZIP/Postal Code

2065

Country

Australia

Facility Name

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Universitair Ziekenhuis Leuven - Gasthuisberg

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Instituto COI de Pesquisa Educação e Gestão

City

Rio de Janeiro

ZIP/Postal Code

22793-080

Country

Brazil

Facility Name

City

Sao Paulo

ZIP/Postal Code

05651-901

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

01308-050

Country

Brazil

Facility Name

Fundação Antonio Prudente - Hospital do Câncer A.C Camargo

City

São Paulo

ZIP/Postal Code

01509-900

Country

Brazil

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

Calgary

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

City

Calgary

ZIP/Postal Code

t2n42n

Country

Canada

Facility Name

City

Newmarket

ZIP/Postal Code

L3Y2P9

Country

Canada

Facility Name

City

Ottawa

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

City

Angers

ZIP/Postal Code

49055

Country

France

Facility Name

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06189

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75248

Country

France

Facility Name

City

Saint Cloud

ZIP/Postal Code

92210

Country

France

Facility Name

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

City

Frankfurt am Main

ZIP/Postal Code

60431

Country

Germany

Facility Name

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22087

Country

Germany

Facility Name

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

City

Achaia

ZIP/Postal Code

26504

Country

Greece

Facility Name

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

City

Sora

ZIP/Postal Code

03039

Country

Italy

Facility Name

City

Daegu

ZIP/Postal Code

41404

Country

Korea, Republic of

Facility Name

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

City

Mexico City

ZIP/Postal Code

14050

Country

Mexico

Facility Name

City

Mexico

ZIP/Postal Code

06700

Country

Mexico

Facility Name

City

México City

ZIP/Postal Code

03310

Country

Mexico

Facility Name

City

Badajoz

ZIP/Postal Code

06080

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

City

Leicester

ZIP/Postal Code

LE1 5WN

Country

United Kingdom

Facility Name

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

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

32353342

Citation

Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, Ricci F, Im SA, Kim SB, Johnston SR, Chan A, Goel S, Catron K, Chapman SC, Price GL, Yang Z, Gainford MC, Andre F. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):763-775. doi: 10.1016/S1470-2045(20)30112-1. Epub 2020 Apr 27. Erratum In: Lancet Oncol. 2021 Mar;22(3):e92. Lancet Oncol. 2021 Nov;22(11):e472.

Results Reference

derived

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/2hkyivX7gUoU2OGI4EcqGA

Description

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

Learn more about this trial

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

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