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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02246621




Registration number
NCT02246621
Ethics application status
Date submitted
18/09/2014
Date registered
23/09/2014

Titles & IDs
Public title
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
Secondary ID [1] 0 0
I3Y-MC-JPBM
Secondary ID [2] 0 0
15417
Universal Trial Number (UTN)
Trial acronym
MONARCH 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Placebo

Experimental: Abemaciclib + NSAI - 150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).

Placebo comparator: Placebo + NSAI - Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).


Treatment: Drugs: Abemaciclib
Administered orally

Treatment: Drugs: Anastrozole
Administered orally

Treatment: Drugs: Letrozole
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)
Secondary outcome [2] 0 0
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Timepoint [2] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)
Secondary outcome [4] 0 0
Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
Timepoint [4] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
Secondary outcome [5] 0 0
Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])
Timepoint [5] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
Secondary outcome [6] 0 0
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Timepoint [6] 0 0
Baseline, End of Study (Up to 32 Months)
Secondary outcome [7] 0 0
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Timepoint [7] 0 0
Baseline, End of Study (Up to 32 Months)
Secondary outcome [8] 0 0
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Timepoint [8] 0 0
Baseline, End of Study (Up to 32 Months)
Secondary outcome [9] 0 0
Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
Timepoint [9] 0 0
Baseline, End of Study (Up to 32 Months)
Secondary outcome [10] 0 0
Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale
Timepoint [10] 0 0
Baseline, End of Study (Up to 32 Months)
Secondary outcome [11] 0 0
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-8)] of Abemaciclib and Its Metabolites M2 and M20
Timepoint [11] 0 0
Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
Secondary outcome [12] 0 0
PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
Timepoint [12] 0 0
Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose

Eligibility
Key inclusion criteria
* Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
* Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
* Have postmenopausal status
* Have either measurable disease or nonmeasurable bone-only disease
* Have a performance status =1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have adequate organ function
* Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
* Are able to swallow capsules
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
* Have inflammatory breast cancer
* Have clinical evidence or a history of central nervous system (CNS) metastasis
* Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
* Have received prior (neo)adjuvant endocrine therapy with a disease-free interval =12 months from completion of treatment
* Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
* Have received prior treatment with everolimus
* Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
* Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
* Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
* Have had major surgery within 14 days prior to randomization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
493
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [4] 0 0
Mater Adult Hospital Brisbane - South Brisbane
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [7] 0 0
Barwon Health - The Geelong Hospital - Geelong
Recruitment hospital [8] 0 0
St. John of God Murdoch Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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Arkansas
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California
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United States of America
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Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
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Minnesota
Country [7] 0 0
United States of America
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Nebraska
Country [8] 0 0
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Nevada
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United States of America
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New York
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United States of America
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Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
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Austria
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Oberösterreich
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Austria
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Steiermark
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Austria
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Tirol
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Wien
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Antwerpen
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Belgium
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Brussel
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Belgium
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Bruxelles-Capitale, Région De
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Belgium
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Charleroi
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Namur
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Roeselare
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Meurthe-et-Moselle
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Vendée
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Besancon Cedex
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Schleswig-Holstein
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Germany
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Hamburg
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Greece
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Attikí
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HaMerkaz
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Israel
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Yerushalayim
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Israel
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Beer Sheva
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Israel
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Kfar Saba
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Israel
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Tel Aviv
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Israel
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?eifa
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BR
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Ferrara
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Liguria
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Torino
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Aichi
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Oaxaca
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Queretaro
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Leiden
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Auckland
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Russian Federation
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Arkhangel'skaya Oblast'
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Russian Federation
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Moskva
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Russian Federation
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Russia
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Russian Federation
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Košický Kraj
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Spain
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Badajoz
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Spain
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Barcelona
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Lleida
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Madrid
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Spain
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San Sebastian
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Spain
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Valencia
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Sweden
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Gavle
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Sweden
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Orebro
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Sweden
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Vasteras
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Taiwan
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Jhonghe City
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Taiwan
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Kuei Shan Hsiang
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Taiwan
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Pei-Tou
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Taiwan
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Taichung
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Taiwan
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Taipei
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Malatya
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United Kingdom
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Bebbington
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United Kingdom
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Cambridge
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United Kingdom
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Manchester
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT02246621