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

COMPLETEDPHASE2

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

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

NCT02675231•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

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
+7 more criteria

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
+2 more criteria

Locations (93)

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

St Jude Medical Center

Fullerton, California, United States

TRIO - Translational Research in Oncology-US, Inc.

Los Angeles, California, United States

USC Norris Cancer Hospital

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Cancer Care Associates Medical Group

Redondo Beach, California, United States

Central Coast Medical Oncology Corporation

Santa Monica, California, United States

Catholic Health Initiatives (CHI)

Englewood, Colorado, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Key Dates

Start Date

May 23, 2016

Primary Completion Date

April 8, 2019

Completion Date

November 9, 2023

Last Updated

November 26, 2024

Enrollment

237

ACTUAL participants

Conditions

Hormone Receptor Positive Breast CancerHER-2 Positive Breast Cancer

Interventions

Abemaciclib

DRUG

Trastuzumab

DRUG

Fulvestrant

DRUG

Standard of Care Single Agent Chemotherapy

DRUG

A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer

NCT07121244

Locoregionally Recurrent Hormone-receptor Positive Breast CancerMetastatic Hormone Receptor Positive Breast Cancer

View study

RECRUITINGPHASE2

PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

NCT07222215

Estrogen-receptor-positive Breast CancerMetastatic Breast Cancer+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer

PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA

A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer

AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer