Breast CancerPhase 2neoMONARCHNCT02441946

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

A Phase 2 study testing Abemaciclib, Loperamide and Anastrozole in people with Breast Cancer and Hormone Receptor Positive Tumor, run by Eli Lilly and Company at 66 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma
What is being tested?: Abemaciclib, Loperamide and Anastrozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 66 sitesin 10 countries
Study dates: Aug 2015to 12 Feb 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

66 sites in 10 countries.

Country

City, postcode or hospital

66 sites in 10 countries

United States27 sites

Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607
Georgia Regents University
Augusta, Georgia, 30912
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
St. Charles Health System
Bend, Oregon, 97701
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
SMO Pharmatech Oncology Inc
Denver, Colorado, 80203
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, 33308
The West Clinic
Germantown, Tennessee, 38138
St Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, 81501
Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
Hollywood, Florida, 33021
Kaiser Foundation Hospitals
Honolulu, Hawaii, 96819
Millennium Oncology
Houston, Texas, 77090
Columbia Basin Hematology & Oncology
Kennewick, Washington, 99336
University of California-San Diego
La Jolla, California, 92037-0845
Nebraska Hematology-Oncology
Lincoln, Nebraska, 68506
SMO TRIO -Translational Research
Los Angeles, California, 90024
UCLA Medical Center
Los Angeles, California, 90024
Oncology and Radiation Associates
Miami, Florida, 33133
Weill Cornell Medical College
New York, New York, 10021
Orlando Health, Inc
Orlando, Florida, 32806
Florida Cancer Research Institute
Plantation, Florida, 33324
Cancer Care Associates Medical Group
Redondo Beach, California, 90277
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Sansum Medical Research Foundation
Santa Barbara, California, 93105
Central Coast Medical Oncology Corporation
Santa Monica, California, 93454
Stanford University
Stanford, California, 94305
University of Massachusetts Medical Center
Worcester, Massachusetts, 80203

Other trials in United States

Germany10 sites

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Berlin, 13125
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Erlangen, 91054
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Essen, 45136
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Esslingen am Neckar, 73730
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Freiburg im Breisgau, 79106
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Fürth, 90766
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Heidelberg, 69120
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Ludwigsburg, 71640
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Tübingen, 72076
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Ulm, 89075

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South Korea7 sites

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Daegu, 41404
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Gangnam-gu, 06351
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Seodaemun-gu, 03722
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Seongbuk-gu, 02841
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Seongnam, 13496
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Songpa-gu, 05505
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Ulsan, 44033

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Belgium4 sites

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Edegem, 2650
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Hasselt, 3500
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Namur, 5000
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Yvoir, 5530

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Italy4 sites

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Milan, 20141
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Naples, 80131
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Padova, 35128
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Piacenza, 29121

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Spain4 sites

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Badajoz, 06080
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Lleida, 25198
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Madrid, 28034
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Málaga, 29010

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Austria3 sites

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Graz, 8036
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Innsbruck, 6020
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Vienna, 1090

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Taiwan3 sites

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Changhua, 500
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Taichung, 40447
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Taipei, 100

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Canada2 sites

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Montreal, H4A 3J1
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Ottawa, K1H 8L6

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Netherlands2 sites

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Maastricht, 6229 HX
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Rotterdam, 3015 GD

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About this study

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

Conditions: Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma
Being tested: Abemaciclib, Loperamide, Anastrozole
Keywords: cyclin-dependent kinase (CDK) 4/6 inhibitor, CDK 4 and 6 inhibitor
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbemaciclibDrug
Also called LY2835219
Administered orally
LoperamideDrug
Administered orally
AnastrozoleDrug
Administered orally

Study groups in NCT02441946
Study group	Role	What they receive
Abemaciclib + Anastrozole	Experimental	Abemaciclib (150 milligrams [mg]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks. Receives: Drug: Abemaciclib; Drug: Loperamide; Drug: Anastrozole
Abemaciclib	Experimental	Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks. Receives: Drug: Abemaciclib; Drug: Loperamide; Drug: Anastrozole
Anastrozole	Active comparator	Anastrozole (1 mg) is given orally QD for 2 weeks. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks. Receives: Drug: Abemaciclib; Drug: Loperamide; Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline to 2 Weeks in Ki67 Expression
Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.
Measured: Baseline, 2 Weeks

Secondary outcomes (6)

Percentage of Participants With Pathologic Complete Response (pCR)
pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.
Measured: From Start of Treatment Up to 16 Weeks
Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response
Clinical objective response is defined as the percentage of participants with the best overall response rate (ORR) with a best OR of CR or PR, according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. ORR is recorded from the start of the study treatment until the earliest of objective progression or start of new anticancer therapy. A responder depends on target and non-target disease and the appearance of new lesions. CR is defined as the disappearance of all non-target lesions. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. All lymph nodes are non-pathological or normal in size (<10mm short axis). Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, a relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm.
Measured: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)
Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response
Radiological response is the percentage of participants with CR or, PR according to RECIST v.1.1. A responder is defined as any participant who exhibits a CR or PR. CR is the disappearance of all target lesions. PR is a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD is 20% increase in the sum of diameters of target lesions taking as reference the smallest sum and the appearance of 1 or more new lesions.
Measured: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, emotional, cognitive, or social functioning), global health status and symptom scales of fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Measured: Baseline, 2 Weeks
Pharmacokinetics (PK): Apparent Clearance of Abemaciclib
Abemaciclib apparent clearance (CL/F) was calculated by population nonlinear mixed effects modeling (NONMEM) using all available data spanning cycles 1 and cycles 3-5.
Measured: 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
PK: Apparent Volume of Distribution of Abemaciclib
Abemaciclib apparent volume of distribution was calculated by population NONMEM using all available data spanning cycles 1 and cycles 3-5.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201512 Feb 2018

First posted12 May 2015 (estimated)
Study startAug 2015
Primary completion16 Aug 2016
Study completion12 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02441946
Sponsor's protocol ID: 15805
Other IDs: I3Y-MC-JPBY, 2014-005486-75, 2014
Acronym: neoMONARCH
Status last verified: Jun 2020
First submitted: 8 May 2015
Last updated: 17 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Expanded access: Available

Publications

Franzoi MA, Lambertini M, Ceppi M, Bruzzone M, de Azambuja E. Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients. Breast Cancer Res Treat. 2022 Apr;192(2):457-462. doi: 10.1007/s10549-022-06525-3. Epub 2022 Jan 25.
PubMed 35076812
Hurvitz SA, Martin M, Press MF, Chan D, Fernandez-Abad M, Petru E, Rostorfer R, Guarneri V, Huang CS, Barriga S, Wijayawardana S, Brahmachary M, Ebert PJ, Hossain A, Liu J, Abel A, Aggarwal A, Jansen VM, Slamon DJ. Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR+/HER2- Breast Cancer. Clin Cancer Res. 2020 Feb 1;26(3):566-580. doi: 10.1158/1078-0432.CCR-19-1425. Epub 2019 Oct 15.
PubMed 31615937

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02441946
Acronym / sponsor ID: neoMONARCH / 15805
Conditions: Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma
Keywords: cyclin-dependent kinase (CDK) 4/6 inhibitor, CDK 4 and 6 inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: 16 Aug 2016 (actual)
Study completion: 12 Feb 2018 (actual)
First posted: 12 May 2015 (estimated)
Results: Posted 30 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Abemaciclib + Anastrozole	Experimental	Drug: Abemaciclib, Drug: Loperamide, Drug: AnastrozoleAbemaciclib (150 milligrams [mg]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
Abemaciclib	Experimental	Drug: Abemaciclib, Drug: Loperamide, Drug: AnastrozoleAbemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
Anastrozole	Active comparator	Drug: Abemaciclib, Drug: Loperamide, Drug: AnastrozoleAnastrozole (1 mg) is given orally QD for 2 weeks. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AbemaciclibAlso: LY2835219Administered orally	Drug	Abemaciclib, Abemaciclib + Anastrozole, Anastrozole
LoperamideAdministered orally	Drug	Abemaciclib, Abemaciclib + Anastrozole, Anastrozole
AnastrozoleAdministered orally	Drug	Abemaciclib, Abemaciclib + Anastrozole, Anastrozole

Primary outcome

Percent Change From Baseline to 2 Weeks in Ki67 Expression
Time frame: Baseline, 2 Weeks
Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.

6 secondary outcomes

Percentage of Participants With Pathologic Complete Response (pCR)
Time frame: From Start of Treatment Up to 16 Weeks
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)
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)
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
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
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

Results and safety

Results posted to the registry on 30 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abemaciclib + Anastrozole	74	72
Abemaciclib	76	71
Anastrozole	74	74

Primary outcome: Percent Change From Baseline to 2 Weeks in Ki67 Expression

Time frame: Baseline, 2 Weeks. Geometric mean (90% Confidence Interval). Unit: Percent Change

Measure	Abemaciclib + Anastrozole n = 59	Abemaciclib n = 52	Anastrozole n = 56
Value	-92.86 (-94.82 to -90.16)	-90.52 (-93.12 to -86.93)	-62.78 (-72.99 to -48.71)

Abemaciclib + Anastrozole vs Anastrozole: Ratio of Geometric Means: 0.19 (90% CI 0.13 to 0.28), p <0.001, t-test, 1 sided
Abemaciclib vs Anastrozole: Ratio of Geometric Means: 0.25 (90% CI 0.17 to 0.38), p <0.001, t-test, 1 sided

Population analysed: All randomized participants who received at least one dose of study drug and a valid baseline Ki67 measurement of at least 5% and a valid 2-week measurement of any magnitude.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abemaciclib + Anastrozole Cycle 1	1 of 74 (1.4%)	62 of 74 (83.8%)	Not reported
Abemaciclib Cycle 1	1 of 75 (1.3%)	58 of 75 (77.3%)	Not reported
Anastrozole Cycle 1	0 of 74 (0%)	17 of 74 (23%)	Not reported
Abemaciclib + Anastrozole Cycle 2 and Beyond	16 of 217 (7.4%)	189 of 217 (87.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35076812Franzoi MA, Lambertini M, Ceppi M, Bruzzone M, de Azambuja E. Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients. Breast Cancer Res Treat. 2022 Apr;192(2):457-462. doi: 10.1007/s10549-022-06525-3. Epub 2022 Jan 25.
Derived from this study: PubMed 31615937Hurvitz SA, Martin M, Press MF, Chan D, Fernandez-Abad M, Petru E, Rostorfer R, Guarneri V, Huang CS, Barriga S, Wijayawardana S, Brahmachary M, Ebert PJ, Hossain A, Liu J, Abel A, Aggarwal A, Jansen VM, Slamon DJ. Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR+/HER2- Breast Cancer. Clin Cancer Res. 2020 Feb 1;26(3):566-580. doi: 10.1158/1078-0432.CCR-19-1425. Epub 2019 Oct 15.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

66 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib, Loperamide and Anastrozole in people with Breast Cancer and Hormone Receptor Positive Tumor, run by Eli Lilly and Company at 66 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Germany, South Korea, Belgium, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to 2 Weeks in Ki67 Expression (time frame: Baseline, 2 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441946, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.