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A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer (neoMONARCH)
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Breast Cancer Hormone Receptor Positive Tumor Early-Stage Breast Carcinoma | Drug: Abemaciclib Drug: Loperamide Drug: Anastrozole | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Anastrozole
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change from Baseline to 2 Weeks in Ki67 Expression [ Time Frame: Baseline, 2 Weeks ]
Secondary Outcome Measures:
- 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) ]
| Enrollment: | 224 |
| Study Start Date: | August 2015 |
| Study Completion Date: | March 2017 |
| Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Drug: Loperamide
Administered orally
Other Name: afatanib
Drug: Anastrozole
Administered orally
|
|
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. |
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Drug: Loperamide
Administered orally
Other Name: afatanib
Drug: Anastrozole
Administered orally
|
|
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. |
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Drug: Loperamide
Administered orally
Other Name: afatanib
Drug: Anastrozole
Administered orally
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02441946
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02441946
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Locations
| United States, California | |
| Comprehensive Blood and Cancer Center | |
| Bakersfield, California, United States, 93309 | |
| University of California-San Diego | |
| La Jolla, California, United States, 92037-0845 | |
| SMO TRIO -Translational Research | |
| Los Angeles, California, United States, 90024 | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90024 | |
| Cancer Care Associates Medical Group | |
| Redondo Beach, California, United States, 90277 | |
| Sansum Medical Research Foundation | |
| Santa Barbara, California, United States, 93105 | |
| Central Coast Medical Oncology Corporation | |
| Santa Monica, California, United States, 93454 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| SMO Pharmatech Oncology Inc | |
| Denver, Colorado, United States, 80203 | |
| St Mary's Hospital Regional Cancer Center | |
| Grand Junction, Colorado, United States, 81501 | |
| United States, Florida | |
| Holy Cross Hospital Inc. | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Memorial Regional Hospital/Joe Dimaggio Childrens Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Oncology and Radiation Associates | |
| Miami, Florida, United States, 33133 | |
| Orlando Health, Inc | |
| Orlando, Florida, United States, 32806 | |
| Florida Cancer Research Institute | |
| Plantation, Florida, United States, 33324 | |
| United States, Georgia | |
| Northeast Georgia Cancer Care, LLC | |
| Athens, Georgia, United States, 30607 | |
| Georgia Regents University | |
| Augusta, Georgia, United States, 30912 | |
| United States, Hawaii | |
| Kaiser Foundation Hospitals | |
| Honolulu, Hawaii, United States, 96819 | |
| United States, Maryland | |
| Walter Reed National Military Medical Center | |
| Bethesda, Maryland, United States, 20889 | |
| United States, Massachusetts | |
| University of Massachusetts Medical Center | |
| Worcester, Massachusetts, United States, 80203 | |
| United States, Nebraska | |
| Nebraska Hematology-Oncology | |
| Lincoln, Nebraska, United States, 68506 | |
| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10021 | |
| United States, Oregon | |
| St. Charles Health System | |
| Bend, Oregon, United States, 97701 | |
| United States, Tennessee | |
| The West Clinic | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Texas | |
| Millennium Oncology | |
| Houston, Texas, United States, 77090 | |
| United States, Utah | |
| Utah Cancer Specialists | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Washington | |
| Columbia Basin Hematology & Oncology | |
| Kennewick, Washington, United States, 99336 | |
| Austria | |
| 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. | |
| Graz, Austria, 8036 | |
| 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. | |
| Innsbruck, Austria, 6020 | |
| 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. | |
| Wien, Austria, 1090 | |
| Belgium | |
| 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. | |
| Edegem, Belgium, 2650 | |
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| Hasselt, Belgium, 3500 | |
| 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. | |
| Namur, Belgium, 5000 | |
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| Yvoir, Belgium, 5530 | |
| Canada | |
| 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. | |
| Montreal, Canada, H4A 3J1 | |
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| Ottawa, Canada, K1H 8L6 | |
| Germany | |
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| Berlin, Germany, 13125 | |
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| Erlangen, Germany, 91054 | |
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| Essen, Germany, 45136 | |
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| Esslingen, Germany, 73730 | |
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| Freiburg, Germany, 79106 | |
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| Furth, Germany, 90766 | |
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| Heidelberg, Germany, 69120 | |
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| Ludwigsburg, Germany, 71640 | |
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| Tubingen, Germany, 72076 | |
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| Ulm, Germany, 89075 | |
| Italy | |
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| Milano, Italy, 20141 | |
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| Napoli, Italy, 80131 | |
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| Padova, Italy, 35128 | |
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| Piacenza, Italy, 29121 | |
| Korea, Republic of | |
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| Daegu, Korea, Republic of, 41404 | |
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| Gangnam-Gu, Korea, Republic of, 06351 | |
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| Seodaemun-gu, Korea, Republic of, 03722 | |
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| Seongbuk-gu, Korea, Republic of, 02841 | |
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| Seongnam, Korea, Republic of, 13496 | |
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| Songpa-gu, Korea, Republic of, 05505 | |
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| Ulsan-si, Korea, Republic of, 44033 | |
| Netherlands | |
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| Maastricht, Netherlands, 6229 HX | |
| 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. | |
| Rotterdam, Netherlands, 3015 GD | |
| Spain | |
| 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. | |
| Badajoz, Spain, 06080 | |
| 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. | |
| Lleida, Spain, 25198 | |
| 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. | |
| Madrid, Spain, 28034 | |
| 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. | |
| Malaga, Spain, 29010 | |
| Taiwan | |
| 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. | |
| Changhua, Taiwan, 500 | |
| 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. | |
| Taichung, Taiwan, 40447 | |
| 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. | |
| Taipei, Taiwan, 100 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT02441946 History of Changes |
| Other Study ID Numbers: |
15805 I3Y-MC-JPBY ( Other Identifier: Eli Lilly and Company ) 2014-005486-75 ( EudraCT Number ) |
| Study First Received: | May 8, 2015 |
| Last Updated: | May 16, 2017 |
| Individual Participant Data (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. |
Keywords provided by Eli Lilly and Company:
|
cyclin-dependent kinase (CDK) 4/6 inhibitor CDK 4 and 6 inhibitor |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Hormones Anastrozole Loperamide Antidiarrheals Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Gastrointestinal Agents |
ClinicalTrials.gov processed this record on July 14, 2017