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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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EUCTR |
Last refreshed on:
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26 March 2018 |
Main ID: |
EUCTR2014-005486-75-NL |
Date of registration:
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29/09/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 2 Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer (neoMONARCH)
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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 - NeoMONARCH |
Date of first enrolment:
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29/09/2015 |
Target sample size:
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220 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005486-75 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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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, Democratic People's 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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Clinical Trial Registry Office
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Address:
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Lilly Corporate Center, DC 1526
46285
Indianapolis
United States |
Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
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Eli Lilly |
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Name:
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Clinical Trial Registry Office
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Address:
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Lilly Corporate Center, DC 1526
46285
Indianapolis
United States |
Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
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Eli Lilly |
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Key inclusion & exclusion criteria
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Inclusion criteria: • are female and =18 years of age • have postmenopausal status • adenocarcinoma of the breast • breast tumor =1 cm in diameter • breast cancer that is 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
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
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:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Postmenopausal Women with Hormone Receptor Postive, HER2 Negative Breast Cancer MedDRA version: 19.0
Level: LLT
Classification code 10007050
Term: Cancer
System Organ Class: 100000004864
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Intervention(s)
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Product Name: Abemaciclib Product Code: Abemaciclib Pharmaceutical Form: Capsule INN or Proposed INN: Abemaciclib CAS Number: 1231929-97-7 Current Sponsor code: LY2835219 Other descriptive name: LY2835219 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Product Name: Anastrozole Product Code: L02B G03 Pharmaceutical Form: Tablet INN or Proposed INN: Anastrozole Other descriptive name: ANASTROZOLE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-
Product Name: loperamide Pharmaceutical Form: Capsule INN or Proposed INN: LOPERAMIDE CAS Number: 53179-11-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2-
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Primary Outcome(s)
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Main Objective: To compare the biological activity of abemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy by assessing the percentage change from the baseline value in Ki67 expression after 2 weeks of therapy.
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Primary end point(s): Percent change in Ki67 expression from baseline to the core biopsy 2 weeks after the start of treatment
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Secondary Objective: • pathologic complete response (pCR) defined as absence of invasive cancer in the breast and sampled regional lymph nodes • clinical objective response (RECIST criteria 1.1) • radiologic response (RECIST criteria 1.1) • safety and tolerability • symptom burden via the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) instrument • pharmacokinetics (PK) of abemaciclib and anastrozole
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Timepoint(s) of evaluation of this end point: Baseline, 2 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 16 weeks
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Secondary end point(s): • pCR defined as absence of invasive cancer in the breast and sampled regional lymph nodes • clinical response of the breast tumor to therapy as assessed by caliper measurement • radiologic response of the breast tumor as assessed by radiologic or ultrasound assessment • adverse events • EORTC QLQ-C30 • PK of abemaciclib and its metabolites and anastrozole • Ki67 • Whole blood, plasma, and tissue samples will be tested for biomarkers relevant to abemaciclib and the disease state and to correlate these markers to clinical outcome and to abemaciclib.
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Secondary ID(s)
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2014-005486-75-ES
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I3Y-MC-JPBY
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Source(s) of Monetary Support
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Eli Lilly and Company
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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