Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02441946 |
Date of registration:
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08/05/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
neoMONARCH |
Scientific title:
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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 |
Date of first enrolment:
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August 2015 |
Target sample size:
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224 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02441946 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Belgium
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Canada
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Germany
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Italy
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Korea, Republic of
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Netherlands
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Spain
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Taiwan
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United States
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Contacts
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Name:
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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) |
Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hormone Receptor Positive Tumor
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Early-Stage Breast Carcinoma
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Breast Cancer
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Intervention(s)
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Drug: Loperamide
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Drug: Abemaciclib
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Drug: Anastrozole
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Primary Outcome(s)
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Percent Change From Baseline to 2 Weeks in Ki67 Expression
[Time Frame: Baseline, 2 Weeks]
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Secondary Outcome(s)
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PK: Apparent Volume of Distribution of Abemaciclib
[Time Frame: Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose]
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Percentage of Participants With Pathologic Complete Response (pCR)
[Time Frame: From Start of Treatment Up to 16 Weeks]
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Pharmacokinetics (PK): Apparent Clearance of Abemaciclib
[Time Frame: Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose]
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Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response
[Time Frame: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)]
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Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response
[Time Frame: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)]
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Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
[Time Frame: Baseline, 2 Weeks]
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Secondary ID(s)
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2014-005486-75
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15805
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I3Y-MC-JPBY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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