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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02246621
Ethics application status
Date submitted
18/09/2014
Date registered
23/09/2014
Date last updated
21/01/2020

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) - PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Timepoint [1] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)
Secondary outcome [1] 0 0
Overall Survival (OS) - OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
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]) - ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Timepoint [2] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)
Secondary outcome [3] 0 0
Duration of Response (DoR) - DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
Timepoint [3] 0 0
CR or PR to Disease Progression or Death Due to Any Cause (Up to 26 Months)
Secondary outcome [4] 0 0
Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) - DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Timepoint [4] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 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]) - CBR defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months / number of participants enrolled) * 100.
Timepoint [5] 0 0
Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 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 - EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Functional scale options are defined on a 7-point scale ranging from 1, "Very poor" to 7, "Excellent". A linear transformation is applied to standardize the raw scores to range between 0 and 100. For functional domains and global health status, higher scores represent a better level of functioning. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate. EORTC change score definitions are described in Cocks et al, (2012) and differ for each item. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.
Timepoint [6] 0 0
Baseline, End of Study (Estimated up to 34 Months)
Secondary outcome [7] 0 0
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores - EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
EORTC change score definitions are described in Cocks et al, (2012) and differ according to each item. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline
Timepoint [7] 0 0
Baseline, End of Study (Estimated up to 34 Months)
Secondary outcome [8] 0 0
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire - The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much" . All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.
Timepoint [8] 0 0
Baseline, End of Study (Estimated up to 34 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) - The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.
Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients, per Pickard et al (2007).
Timepoint [9] 0 0
Baseline, End of Study (Estimated up to 34 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 - The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients, per Pickard et al (2007).
Timepoint [10] 0 0
Baseline, End of Study (Estimated up to 34 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Camperdown
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fitzroy
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Geelong
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Murdoch
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - South Brisbane
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wahroonga
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woodville
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
2076 - Wahroonga
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
5011 - Woodville
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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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
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors
(NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be
randomized to abemaciclib or placebo in a 2:1 ratio.
Trial website
https://clinicaltrials.gov/show/NCT02246621
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

Summary results
Other publications