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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03155997
Ethics application status
Date submitted
15/05/2017
Date registered
16/05/2017

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: 150 mg Abemaciclib + Endocrine Therapy - Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.

Other: Endocrine Therapy - Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.


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)
Timepoint [1] 0 0
Baseline to Recurrence or Death from Any Cause (Up to 32 Months)
Secondary outcome [1] 0 0
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)
Timepoint [2] 0 0
Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)
Secondary outcome [3] 0 0
Overall Survival (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
Timepoint [4] 0 0
Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose
Secondary outcome [5] 0 0
Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (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)
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)
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)
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
Sex
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
12/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/05/2029
Actual
Sample size
Target
Accrual to date
Final
5637
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
St Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
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Calvary Mater Newcastle - Newcastle
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Mater Hospital Sydney - Sydney
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Southern Medical Day Care Centre - Wollongong
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Mater Misericordiae Limited - Brisbane
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Gold Coast University Hospital - Southport
Recruitment hospital [11] 0 0
The Townsville Hospital - Townsville
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Lyell McEwin Hospital - Elizabeth Vale
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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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Epworth Research Institute - East Melbourne
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Peter MacCallum Cancer Centre - Melbourne
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Maroondah Hospital - Melbourne
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Breast Cancer Research Centre WA - Nedlands
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St John of God Hospital - Subiaco - Subiaco
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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2010 - Darlinghurst
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2480 - Lismore
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2170 - Liverpool
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2298 - Newcastle
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2060 - Sydney
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2145 - Westmead
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2500 - Wollongong
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4101 - Brisbane
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4215 - Southport
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4814 - Townsville
Recruitment postcode(s) [12] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [13] 0 0
5037 - Kurralta Park
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7250 - Launceston
Recruitment postcode(s) [15] 0 0
3128 - Box Hill
Recruitment postcode(s) [16] 0 0
3121 - East Melbourne
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3050 - Melbourne
Recruitment postcode(s) [18] 0 0
3135 - Melbourne
Recruitment postcode(s) [19] 0 0
6009 - Nedlands
Recruitment postcode(s) [20] 0 0
6008 - Subiaco
Recruitment outside Australia
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West Bengal
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State/province [182] 0 0
Torino
Country [183] 0 0
Italy
State/province [183] 0 0
Trento
Country [184] 0 0
Japan
State/province [184] 0 0
Aichi
Country [185] 0 0
Japan
State/province [185] 0 0
Chiba
Country [186] 0 0
Japan
State/province [186] 0 0
Ehime
Country [187] 0 0
Japan
State/province [187] 0 0
Fukuoka
Country [188] 0 0
Japan
State/province [188] 0 0
Gunma
Country [189] 0 0
Japan
State/province [189] 0 0
Hiroshima-ken
Country [190] 0 0
Japan
State/province [190] 0 0
Hokkaido
Country [191] 0 0
Japan
State/province [191] 0 0
Hyogo
Country [192] 0 0
Japan
State/province [192] 0 0
Ibaragi
Country [193] 0 0
Japan
State/province [193] 0 0
Kanagawa
Country [194] 0 0
Japan
State/province [194] 0 0
Miyagi
Country [195] 0 0
Japan
State/province [195] 0 0
Niigata
Country [196] 0 0
Japan
State/province [196] 0 0
Osaka
Country [197] 0 0
Japan
State/province [197] 0 0
Saitama
Country [198] 0 0
Japan
State/province [198] 0 0
Shizuoka
Country [199] 0 0
Japan
State/province [199] 0 0
Tochigi
Country [200] 0 0
Japan
State/province [200] 0 0
Tokyo
Country [201] 0 0
Japan
State/province [201] 0 0
Kagoshima
Country [202] 0 0
Japan
State/province [202] 0 0
Kumamoto
Country [203] 0 0
Japan
State/province [203] 0 0
Kyoto
Country [204] 0 0
Korea, Republic of
State/province [204] 0 0
Chungcheongbuk-do [Chungbuk]
Country [205] 0 0
Korea, Republic of
State/province [205] 0 0
Chungcheongnam-do [Chungnam]
Country [206] 0 0
Korea, Republic of
State/province [206] 0 0
Gyeonggi-do
Country [207] 0 0
Korea, Republic of
State/province [207] 0 0
Incheon-gwangyeoksi [Incheon]
Country [208] 0 0
Korea, Republic of
State/province [208] 0 0
Kyonggi-do
Country [209] 0 0
Korea, Republic of
State/province [209] 0 0
Pusan-Kwangyokshi
Country [210] 0 0
Korea, Republic of
State/province [210] 0 0
Seoul-teukbyeolsi [Seoul]
Country [211] 0 0
Korea, Republic of
State/province [211] 0 0
Taegu-Kwangyokshi
Country [212] 0 0
Mexico
State/province [212] 0 0
Coahuila
Country [213] 0 0
Mexico
State/province [213] 0 0
Distrito Federal
Country [214] 0 0
Mexico
State/province [214] 0 0
Federal District
Country [215] 0 0
Mexico
State/province [215] 0 0
Jalisco
Country [216] 0 0
Mexico
State/province [216] 0 0
Nuevo Leon
Country [217] 0 0
Mexico
State/province [217] 0 0
Nuevo León
Country [218] 0 0
Mexico
State/province [218] 0 0
Oaxaca
Country [219] 0 0
Mexico
State/province [219] 0 0
Sinaloa
Country [220] 0 0
Mexico
State/province [220] 0 0
Toluca
Country [221] 0 0
Mexico
State/province [221] 0 0
Yucatan
Country [222] 0 0
Mexico
State/province [222] 0 0
Chihuahua
Country [223] 0 0
Mexico
State/province [223] 0 0
Puebla
Country [224] 0 0
Mexico
State/province [224] 0 0
San Luis Potosí
Country [225] 0 0
Netherlands
State/province [225] 0 0
Limburg
Country [226] 0 0
Netherlands
State/province [226] 0 0
Noord-Holland
Country [227] 0 0
Netherlands
State/province [227] 0 0
Zuid-Holland
Country [228] 0 0
New Zealand
State/province [228] 0 0
Waikato
Country [229] 0 0
New Zealand
State/province [229] 0 0
Wanganui
Country [230] 0 0
New Zealand
State/province [230] 0 0
Auckland
Country [231] 0 0
Poland
State/province [231] 0 0
Dolnoslaskie
Country [232] 0 0
Poland
State/province [232] 0 0
Lubelskie
Country [233] 0 0
Poland
State/province [233] 0 0
Mazowieckie
Country [234] 0 0
Poland
State/province [234] 0 0
Opolskie
Country [235] 0 0
Poland
State/province [235] 0 0
Pomorskie
Country [236] 0 0
Poland
State/province [236] 0 0
Warminsko-mazurskie
Country [237] 0 0
Poland
State/province [237] 0 0
Wielkopolskie
Country [238] 0 0
Poland
State/province [238] 0 0
Lódzkie
Country [239] 0 0
Portugal
State/province [239] 0 0
Coimbra
Country [240] 0 0
Portugal
State/province [240] 0 0
Lisboa
Country [241] 0 0
Portugal
State/province [241] 0 0
Porto
Country [242] 0 0
Puerto Rico
State/province [242] 0 0
Bayamon
Country [243] 0 0
Puerto Rico
State/province [243] 0 0
San Juan
Country [244] 0 0
Romania
State/province [244] 0 0
Cluj
Country [245] 0 0
Romania
State/province [245] 0 0
Constanta
Country [246] 0 0
Romania
State/province [246] 0 0
Dolj
Country [247] 0 0
Romania
State/province [247] 0 0
Ilfov
Country [248] 0 0
Romania
State/province [248] 0 0
Maramure?
Country [249] 0 0
Romania
State/province [249] 0 0
Sector 2
Country [250] 0 0
Romania
State/province [250] 0 0
Bucuresti
Country [251] 0 0
Russian Federation
State/province [251] 0 0
Kalužskaja Oblast'
Country [252] 0 0
Russian Federation
State/province [252] 0 0
Kurskaya Oblast'
Country [253] 0 0
Russian Federation
State/province [253] 0 0
Moskva
Country [254] 0 0
Russian Federation
State/province [254] 0 0
Orenburgskaya Oblast'
Country [255] 0 0
Russian Federation
State/province [255] 0 0
Samarskaya Oblast'
Country [256] 0 0
Russian Federation
State/province [256] 0 0
Sankt-Peterburg
Country [257] 0 0
Russian Federation
State/province [257] 0 0
Tatarstan Republic
Country [258] 0 0
Russian Federation
State/province [258] 0 0
Volgogradskaya Oblast'
Country [259] 0 0
Russian Federation
State/province [259] 0 0
Yaroslavskaya Oblast'
Country [260] 0 0
Russian Federation
State/province [260] 0 0
Chelyabinsk
Country [261] 0 0
Russian Federation
State/province [261] 0 0
Moscow
Country [262] 0 0
Russian Federation
State/province [262] 0 0
Saint-Petersburg
Country [263] 0 0
Russian Federation
State/province [263] 0 0
St. Petersburg
Country [264] 0 0
Saudi Arabia
State/province [264] 0 0
Ar Riya?
Country [265] 0 0
Saudi Arabia
State/province [265] 0 0
Ash Sharqiyah
Country [266] 0 0
Saudi Arabia
State/province [266] 0 0
Riyadh
Country [267] 0 0
Singapore
State/province [267] 0 0
Central Singapore
Country [268] 0 0
Singapore
State/province [268] 0 0
Singapore
Country [269] 0 0
South Africa
State/province [269] 0 0
Eastern Cape
Country [270] 0 0
South Africa
State/province [270] 0 0
Gauteng
Country [271] 0 0
South Africa
State/province [271] 0 0
Western Cape
Country [272] 0 0
Spain
State/province [272] 0 0
Andalucía
Country [273] 0 0
Spain
State/province [273] 0 0
Asturias
Country [274] 0 0
Spain
State/province [274] 0 0
Barcelona [Barcelona]
Country [275] 0 0
Spain
State/province [275] 0 0
Catalunya [Cataluña]
Country [276] 0 0
Spain
State/province [276] 0 0
Cataluña
Country [277] 0 0
Spain
State/province [277] 0 0
La Coruna
Country [278] 0 0
Spain
State/province [278] 0 0
Madrid, Comunidad De
Country [279] 0 0
Spain
State/province [279] 0 0
Madrid
Country [280] 0 0
Spain
State/province [280] 0 0
Málaga
Country [281] 0 0
Spain
State/province [281] 0 0
Santa Cruz De Tenerife
Country [282] 0 0
Spain
State/province [282] 0 0
Valenciana, Comunitat
Country [283] 0 0
Spain
State/province [283] 0 0
Barcelona
Country [284] 0 0
Spain
State/province [284] 0 0
Granada
Country [285] 0 0
Spain
State/province [285] 0 0
Jaen
Country [286] 0 0
Spain
State/province [286] 0 0
Salamanca
Country [287] 0 0
Spain
State/province [287] 0 0
Sevilla
Country [288] 0 0
Spain
State/province [288] 0 0
Valencia
Country [289] 0 0
Spain
State/province [289] 0 0
Zaragoza
Country [290] 0 0
Sweden
State/province [290] 0 0
Västerbottens Län [se-24]
Country [291] 0 0
Sweden
State/province [291] 0 0
Västernorrlands Län [se-22]
Country [292] 0 0
Sweden
State/province [292] 0 0
Västmanlands Län [se-19]
Country [293] 0 0
Sweden
State/province [293] 0 0
Lund
Country [294] 0 0
Sweden
State/province [294] 0 0
Växjö
Country [295] 0 0
Taiwan
State/province [295] 0 0
Kaohsiung
Country [296] 0 0
Taiwan
State/province [296] 0 0
Changhua
Country [297] 0 0
Taiwan
State/province [297] 0 0
Kaohsiung City
Country [298] 0 0
Taiwan
State/province [298] 0 0
Neihu Taipei
Country [299] 0 0
Taiwan
State/province [299] 0 0
New Taipei City
Country [300] 0 0
Taiwan
State/province [300] 0 0
Taichung
Country [301] 0 0
Taiwan
State/province [301] 0 0
Taipei City
Country [302] 0 0
Taiwan
State/province [302] 0 0
Taipei
Country [303] 0 0
Taiwan
State/province [303] 0 0
Taoyuan City
Country [304] 0 0
Turkey
State/province [304] 0 0
Istanbul
Country [305] 0 0
Turkey
State/province [305] 0 0
Izmir
Country [306] 0 0
Turkey
State/province [306] 0 0
Kecioren
Country [307] 0 0
Turkey
State/province [307] 0 0
Adana
Country [308] 0 0
Turkey
State/province [308] 0 0
Ankara
Country [309] 0 0
Turkey
State/province [309] 0 0
Antalya
Country [310] 0 0
Turkey
State/province [310] 0 0
Edirne
Country [311] 0 0
Turkey
State/province [311] 0 0
Kocaeli
Country [312] 0 0
Turkey
State/province [312] 0 0
Malatya
Country [313] 0 0
Ukraine
State/province [313] 0 0
Dnipropetrovska Oblast
Country [314] 0 0
Ukraine
State/province [314] 0 0
Odeska Oblast
Country [315] 0 0
Ukraine
State/province [315] 0 0
Poltavska Oblast
Country [316] 0 0
Ukraine
State/province [316] 0 0
Vinnytska Oblast
Country [317] 0 0
Ukraine
State/province [317] 0 0
Volynska Oblast
Country [318] 0 0
Ukraine
State/province [318] 0 0
Zakarpatska Oblast
Country [319] 0 0
United Kingdom
State/province [319] 0 0
England
Country [320] 0 0
United Kingdom
State/province [320] 0 0
Essex
Country [321] 0 0
United Kingdom
State/province [321] 0 0
Greater London
Country [322] 0 0
United Kingdom
State/province [322] 0 0
Hammersmith And Fulham
Country [323] 0 0
United Kingdom
State/province [323] 0 0
Hertfordshire
Country [324] 0 0
United Kingdom
State/province [324] 0 0
Lancashire
Country [325] 0 0
United Kingdom
State/province [325] 0 0
Lincolnshire
Country [326] 0 0
United Kingdom
State/province [326] 0 0
Middlesbrough
Country [327] 0 0
United Kingdom
State/province [327] 0 0
Midlothian
Country [328] 0 0
United Kingdom
State/province [328] 0 0
Nottinghamshire
Country [329] 0 0
United Kingdom
State/province [329] 0 0
Oxfordshire
Country [330] 0 0
United Kingdom
State/province [330] 0 0
Somerset
Country [331] 0 0
United Kingdom
State/province [331] 0 0
Surrey
Country [332] 0 0
United Kingdom
State/province [332] 0 0
Bradford
Country [333] 0 0
United Kingdom
State/province [333] 0 0
Manchester

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
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

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03155997