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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03155997




Registration number
NCT03155997
Ethics application status
Date submitted
15/05/2017
Date registered
16/05/2017
Date last updated
16/07/2019

Titles & IDs
Public title
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
Scientific title
A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
Secondary ID [1] 0 0
I3Y-MC-JPCF
Secondary ID [2] 0 0
16338
Universal Trial Number (UTN)
Trial acronym
monarchE
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 - Standard Adjuvant Endocrine Therapy

Experimental: Abemaciclib + Standard Adjuvant Endocrine Therapy - Abemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.

Other: Standard Adjuvant Endocrine Therapy - Standard adjuvant endocrine therapy administered according to package label.


Treatment: Drugs: Abemaciclib
Administered orally.

Treatment: Drugs: Standard Adjuvant Endocrine Therapy
Administered according to label instructions.

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

Outcomes
Primary outcome [1] 0 0
Invasive Disease Free Survival (IDFS) - IDFS
Timepoint [1] 0 0
Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)
Secondary outcome [1] 0 0
IDFS for Participants with Ki-67 Index =20% - IDFS for participants with Ki-67 index =20%
Timepoint [1] 0 0
Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)
Secondary outcome [2] 0 0
Distant Relapse-Free Survival (DRFS) - DRFS
Timepoint [2] 0 0
Baseline to Distant Recurrence or Death from Any Cause (Approximately 10 Years)
Secondary outcome [3] 0 0
Overall Survival (OS) - OS
Timepoint [3] 0 0
Baseline to Death from Any Cause (Approximately 10 Years)
Secondary outcome [4] 0 0
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib - PK: Cmin,ss of Abemaciclib
Timepoint [4] 0 0
Post Dose Day 1 through Month 3
Secondary outcome [5] 0 0
Change from Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B) - Change from Baseline on the FACT-B
Timepoint [5] 0 0
Baseline, Follow Up (Approximately 3 Years)
Secondary outcome [6] 0 0
Change from Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) - Change from Baseline on the FACT-ES
Timepoint [6] 0 0
Baseline, Follow Up (Approximately 3 Years)
Secondary outcome [7] 0 0
Change from Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) - Change from Baseline on the FACIT-F
Timepoint [7] 0 0
Baseline, Follow Up (Approximately 3 Years)
Secondary outcome [8] 0 0
Change from Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) - Change from Baseline on the EQ-5D-5L
Timepoint [8] 0 0
Baseline, Follow Up (Approximately 3 Years)

Eligibility
Key inclusion criteria
- Women (regardless of menopausal status) or men =18 years of age (or per local
regulations).

- The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer
without evidence of distant metastases.

- The participant must have undergone definitive surgery of the primary breast tumor.

- The participant must have tumor tissue from breast (preferred) or lymph node for
exploratory biomarker analysis available prior to randomization.

- Pathologic lymph node involvement and at least one of the following indicating a
higher risk of recurrence:

- 4 or more positive axillary lymph nodes

- Tumor size of at least 5 centimeters

- Grade 3 defined as at least 8 points on the Bloom Richardson grading system

- Ki-67 index by central analysis of =20% on untreated breast tissue

- The participant must be randomized within 16 months from the time of definitive breast
cancer surgery.

- The participant may receive up to 12 weeks of endocrine therapy until randomization
following the last non-endocrine therapy (surgery, chemotherapy, or radiation)
whichever is last.

- Participants must have recovered (grade =1) from the acute effects of chemotherapy and
radiotherapy and from surgical side effects following definitive breast surgery.

- Women of reproductive potential must have a negative blood pregnancy test and agree to
use highly effective contraceptive methods.

- The participant has a Eastern Cooperative Oncology Group (ECOG) performance status =1.

- The participant has adequate organ function.

- The participant is able to swallow oral medications.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Metastatic disease (including contralateral axillary lymph nodes) or node-negative
disease.

- Participants with inflammatory breast cancer.

- Participants with a history of previous breast cancer, with the exception of
ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone =5
years ago. Participants with a history of contralateral DCIS treated by local regional
therapy at any time may be eligible. Participants with a history of any other cancer
(except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in
complete remission with no therapy for a minimum of 5 years from the date of
randomization are excluded.

- Females who are pregnant or lactating.

- The participant has previously received treatment with any CDK4 and CDK6 inhibitor.

- The participant is receiving concurrent exogenous reproductive hormone therapy (for
example, birth control pills, hormone replacement therapy, or megestrol acetate).

- The participant has previously received endocrine therapy for breast cancer prevention
(tamoxifen or aromatase inhibitors) or raloxifene.

- The participant has serious preexisting medical condition(s) that, in the judgment of
the investigator, would preclude participation in this study.

- The participant has a personal history of any of the following conditions: syncope of
cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden
cardiac arrest. Any participant with a history of venous thromboembolism (VTE).

- The participant has active systemic infections or viral load.

- The participant has received an experimental treatment in a clinical trial within the
last 30 days or 5 half-lives, whichever is longer.

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
Open (masking not used)
Who is / are masked / blinded?



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)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [5] 0 0
Mater Private Hospital - North Sydney
Recruitment hospital [6] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [9] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [10] 0 0
Mater Adult Hospital Brisbane - South Brisbane
Recruitment hospital [11] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [12] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [13] 0 0
Ashford Cancer Centre Research - Kurralta Park
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Launceston General Hospital - Launceston
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Box Hill Hospital - Box Hill
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Peter MacCallum Cancer Centre - Melbourne
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Epworth Research Institute - Richmond
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Eastern Health, Maroondah Hospital - Ringwood East
Recruitment hospital [19] 0 0
St John of God Hospital - Subiaco - Subiaco
Recruitment hospital [20] 0 0
Breast Cancer Research Centre WA - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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2480 - Lismore
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2170 - Liverpool
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2298 - Newcastle
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2291 - North Sydney
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2010 - Sydney
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2145 - Westmead
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2500 - Wollongong
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4814 - Douglas
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4101 - South Brisbane
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4215 - Southport
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5112 - Elizabeth Vale
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5037 - Kurralta Park
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7250 - Launceston
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3128 - Box Hill
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3000 - Melbourne
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3121 - Richmond
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3135 - Ringwood East
Recruitment postcode(s) [19] 0 0
6008 - Subiaco
Recruitment postcode(s) [20] 0 0
6009 - Nedlands
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NSABP Foundation Inc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the study drug
abemaciclib in participants with high risk, node positive, early stage, hormone receptor
positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Trial website
https://clinicaltrials.gov/show/NCT03155997
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