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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT02441946

First received: May 8, 2015

Last updated: May 16, 2017

Last verified: May 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2015

Last Updated Date

May 16, 2017

Start Date ^ICMJE

August 2015

Primary Completion Date

August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from Baseline to 2 Weeks in Ki67 Expression [ Time Frame: Baseline, 2 Weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02441946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of Participants with Pathologic Complete Response (pCR) [ Time Frame: 16 Weeks ]
Percentage of Participants with Complete Response (CR) or Partial Response (PR): Clinical Objective Response [ Time Frame: 16 Weeks ]
Percentage of Participants with Complete Radiologic Response or Partial Radiological Response: Radiological Response [ Time Frame: 16 Weeks ]
Change from Baseline to Week 2 in Toxicity Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline, 2 Weeks ]
Pharmacokinetics (PK): Clearance of Abemaciclib and Anastrozole [ Time Frame: Postdose Cycle 1 Day 1 through Cyle 5 Day 28 (Approximately 16 Weeks) ]
PK: Volume of Distribution of Abemaciclib and Anastrozole [ Time Frame: Postdose Cycle 1 Day 1 through Cyle 5 Day 28 (Approximately 16 Weeks) ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer
Hormone Receptor Positive Tumor
Early-Stage Breast Carcinoma

Intervention ^ICMJE

Drug: Abemaciclib
Administered orally

Other Name: LY2835219
Drug: Loperamide
Administered orally

Other Name: afatanib
Drug: Anastrozole
Administered orally

Study Arms

Experimental: Abemaciclib + Anastrozole
Abemaciclib and loperamide orally every 12 hours plus anastrozole orally once daily for 14 days.

Every participant will then receive abemaciclib and loperamide orally every 12 hours plus anastrozole orally once daily for 14 weeks.
Interventions:
- Drug: Abemaciclib
- Drug: Loperamide
- Drug: Anastrozole
Active Comparator: Anastrozole
Anastrozole orally once daily for 14 days.

Every participant will then receive abemaciclib and loperamide orally every 12 hours plus anastrozole orally once daily for 14 weeks.
Interventions:
- Drug: Abemaciclib
- Drug: Loperamide
- Drug: Anastrozole
Experimental: Abemaciclib
Abemaciclib and loperamide orally every 12 hours for 14 days.

Every participant will then receive abemaciclib and loperamide orally every 12 hours plus anastrozole orally once daily for 14 weeks.
Interventions:
- Drug: Abemaciclib
- Drug: Loperamide
- Drug: Anastrozole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

224

Completion Date

March 2017

Primary Completion Date

August 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Austria, Belgium, Canada, Germany, Italy, Korea, Republic of, Netherlands, Spain, Taiwan, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02441946

Other Study ID Numbers ^ICMJE

15805
I3Y-MC-JPBY ( Other Identifier: Eli Lilly and Company )
2014-005486-75 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Yes

Plan Description:

Lilly provides access to the individual participant data from studies on approved medicines and indications as defined by the sponsor specific information on linicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Responsible Party

Eli Lilly and Company

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

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

PRS Account

Eli Lilly and Company

Verification Date

May 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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