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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02107703




Registration number
NCT02107703
Ethics application status
Date submitted
4/04/2014
Date registered
8/04/2014

Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Scientific title
MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
I3Y-MC-JPBL
Secondary ID [2] 0 0
15362
Universal Trial Number (UTN)
Trial acronym
MONARCH 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 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 - Fulvestrant
Treatment: Drugs - Placebo

Experimental: Abemaciclib + Fulvestrant - Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.

Placebo comparator: Placebo + Fulvestrant - Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.


Treatment: Drugs: Abemaciclib
Administered Orally

Treatment: Drugs: Fulvestrant
Administered IM

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
From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From Date of Randomization until Death Due to Any Cause (Up To 72 Months)
Secondary outcome [2] 0 0
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Timepoint [2] 0 0
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Secondary outcome [4] 0 0
Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
Timepoint [4] 0 0
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Secondary outcome [5] 0 0
Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])
Timepoint [5] 0 0
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Secondary outcome [6] 0 0
Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Timepoint [6] 0 0
Baseline, End of Study (Up To 31 Months)
Secondary outcome [7] 0 0
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20
Timepoint [7] 0 0
Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose
Secondary outcome [8] 0 0
Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
Timepoint [8] 0 0
Baseline, End of Study (Up To 31 Months)
Secondary outcome [9] 0 0
Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Timepoint [9] 0 0
Baseline, Short Term Follow Up (Up To 31 Months)
Secondary outcome [10] 0 0
Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire
Timepoint [10] 0 0
Baseline, Short Term Follow Up (Up To 31 Months)

Eligibility
Key inclusion criteria
Inclusion Criteria

* Have a diagnosis of HR+, HER2- breast cancer
* Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:

* relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
* relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
* relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
* presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
* for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting
* Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
* Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
* Have either measurable disease or nonmeasurable bone only disease
* Have a performance status =1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* 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 visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
* Have clinical evidence or history of central nervous system metastasis
* Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
* Have received recent (within 28 days prior to randomization) yellow fever vaccination
* Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
* Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
* Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
* Have received an autologous or allogeneic stem-cell transplant
* Have active bacterial or fungal infection, or detectable viral infection
* Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents <7 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 analysing the results/data
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
22/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
669
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [2] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [4] 0 0
Monash Cancer Centre - East Bentleigh
Recruitment hospital [5] 0 0
St. John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
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Georgia
Country [5] 0 0
United States of America
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Illinois
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United States of America
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Maryland
Country [7] 0 0
United States of America
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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New Hampshire
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New York
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North Carolina
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Oklahoma
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South Dakota
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Tennessee
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Texas
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Utah
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Washington
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Belgium
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Antwerpen
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Belgium
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Bruxelles-Capitale, Région De
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Belgium
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Liège
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Hovedstaden
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Aalborg
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Roskilde
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Sankt-Peterburg
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Kursk
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Spain
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Alicante
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Barcelona [Barcelona]
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Lleida [Lérida]
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Spain
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Madrid, Comunidad De
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Murcia, Región De
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Spain
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València
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Madrid
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Switzerland
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Basel Stadt
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Switzerland
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Berne
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Switzerland
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Genève
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan

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 European Union (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: http://www.clinicalstudydatarequest.com


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol: JPBL 05 Protocol_Redacted https://cdn.clinicaltrials.gov/large-docs/03/NCT02107703/Prot_000.pdf
Study protocol Study Protocol: JPBL 05 Protocol (a)_Redacted https://cdn.clinicaltrials.gov/large-docs/03/NCT02107703/Prot_001.pdf
Study protocol Study Protocol: JPBL 05 Protocol (b)_Redacted https://cdn.clinicaltrials.gov/large-docs/03/NCT02107703/Prot_002.pdf
Study protocol Study Protocol: JPBL 05 Protocol (c)_Redacted https://cdn.clinicaltrials.gov/large-docs/03/NCT02107703/Prot_003.pdf
Study protocol Study Protocol: JPBL 05 Protocol (d)_Redacted https://cdn.clinicaltrials.gov/large-docs/03/NCT02107703/Prot_004.pdf
Study protocol Study Protocol: JPBL 05 Protocol (g)_Redacted https://cdn.clinicaltrials.gov/large-docs/03/NCT02107703/Prot_007.pdf
Statistical analysis plan Statistical Analysis Plan: version 4 https://cdn.clinicaltrials.gov/large-docs/03/NCT02107703/SAP_005.pdf
Statistical analysis plan Statistical Analysis Plan: Addendum for Overall Su... [More Details] https://cdn.clinicaltrials.gov/large-docs/03/NCT02107703/SAP_006.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02107703