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

COMPLETEDPHASE2

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

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

NCT02441946•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

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.

Locations (66)

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

University of California-San Diego

La Jolla, California, United States

SMO TRIO -Translational Research

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Cancer Care Associates Medical Group

Redondo Beach, California, United States

Sansum Medical Research Foundation

Santa Barbara, California, United States

Central Coast Medical Oncology Corporation

Santa Monica, California, United States

Stanford University

Stanford, California, United States

SMO Pharmatech Oncology Inc

Denver, Colorado, United States

St Mary's Hospital Regional Cancer Center

Grand Junction, Colorado, United States

Key Dates

Start Date

August 1, 2015

Primary Completion Date

August 16, 2016

Completion Date

February 12, 2018

Last Updated

June 17, 2020

Enrollment

224

ACTUAL participants

Conditions

Breast CancerHormone Receptor Positive TumorEarly-Stage Breast Carcinoma

Interventions

Abemaciclib

DRUG

Loperamide

DRUG

Anastrozole

DRUG

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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: June 17, 2020Data 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 Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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