Hormone Receptor Positive Breast CancerPhase 2monarcHERNCT02675231
A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing Abemaciclib, Trastuzumab and Fulvestrant in people with Hormone Receptor Positive Breast Cancer and HER-2 Positive Breast Cancer, run by Eli Lilly and Company at 93 sites in 14 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Receptor Positive Breast Cancer, HER-2 Positive Breast Cancer
- What is being tested?
- Abemaciclib, Trastuzumab and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 93 sitesin 14 countries
- Study dates
- 23 May 2016to 9 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of HR+, HER2+ breast cancer (BC)
- unresectable locally advanced recurrent BC or metastatic BC
- adequate tumor tissue available prior to randomization
- measurable and/or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- previously received:
- at least 2 HER2-directed therapies for advanced disease
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- participant must have received trastuzumab emtansine (T-DM1) in any disease setting
- must have received a taxane in any disease setting
- may have received any endocrine therapy (excluding fulvestrant)
- have postmenopausal status due to surgical / natural menopause or chemical ovarian suppression
- performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale
- left ventricular ejection fraction (LVEF) of 50% or higher at baseline
- adequate organ function
- 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 menopause induced by gonadotropin-releasing hormone (GnRH) agonist or radiation
- discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy
- discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy), except trastuzumab, 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
- are able to swallow capsules
Who cannot join
- have visceral crisis
- known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms
- had major surgery within 14 days prior to randomization
- received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor
- 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 serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
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- history within the last 6 months of symptomatic congestive heart failure, myocardial infarction, or unstable angina
- history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
- 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 3 years
- active bacterial, fungal infection, or detectable viral infection
- have received any recent (within 28 days prior to randomization) live virus vaccination
- hypersensitivity to trastuzumab, murine proteins, fulvestrant, or to any of the excipients
Trial locations and contacts
93 sites in 14 countries.
93 sites in 14 countries
United States32 sites
Winship Cancer Center Emory University
Atlanta, Georgia, 30322
Northside Hospital Cancer Institute
Atlanta, Georgia, 30342
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Billings Clinic Research Center
Billings, Montana, 59101
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Brookdale Hospital Medical Center
Brooklyn, New York, 11212
North Shore Hematology Oncology Associates
East Setauket, New York, 11733
Catholic Health Initiatives (CHI)
Englewood, Colorado, 80112
Florida Cancer Specialists
Fort Myers, Florida, 33901
Florida Cancer Specialists
Fort Myers, Florida, 33908
Fort Wayne Medical Oncology & Hematology, Inc.
Fort Wayne, Indiana, 46845
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
St Jude Medical Center
Fullerton, California, 92835
Clinical Research Alliance, Inc
Lake Success, New York, 11042
St Joseph Cancer Center
Lexington, Kentucky, 40509
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, 90024
USC Norris Cancer Hospital
Los Angeles, California, 90033
UCLA Medical Center
Los Angeles, California, 90095
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
University of Miami Plantation
Plantation, Florida, 33324
Northwest Medical Specialties, PLLC
Puyallup, Washington, 98372
Cancer Care Associates Medical Group
Redondo Beach, California, 90277
Mayo Clinic
Rochester, Minnesota, 55902
Mayo Clinic
Rochester, Minnesota, 55905
Central Coast Medical Oncology Corporation
Santa Monica, California, 93454
Swedish Medical Center
Seattle, Washington, 98104
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Florida Cancer Specialists
St. Petersburg, Florida, 33705
Argentina9 sites
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Buenos Aires, 1426
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CABA, 1025
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Córdoba, X5000JHGQ
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Córdoba, X5000JHQ
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La Rioja, 5300
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Rosario, 2000
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Rosario, S2000DSV
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San Miguel de Tucumán, T4000IAK
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Viedma, 8500
France8 sites
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Angers, 49055
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Besançon, 25030
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Lyon, 69373
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Montpellier, 34298
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Nice, 06189
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Paris, 75248
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Saint-Cloud, 92210
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Villejuif, 94805
South Korea8 sites
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Daegu, 41404
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Goyang-si, 10408
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Seongnam-si, 13620
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Seoul, 02841
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06351
Brazil5 sites
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Porto Alegre, 90610-000
Instituto COI de Pesquisa Educação e Gestão
Rio de Janeiro, 22793-080
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São Paulo, 01308-050
Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
São Paulo, 01509-900
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São Paulo, 05651-901
Spain5 sites
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Badajoz, 06080
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Barcelona, 08035
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Madrid, 28034
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Madrid, 28040
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Seville, 41013
Belgium4 sites
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Charleroi, 6000
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Ghent, 9000
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven, 3000
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Namur, 5000
Canada4 sites
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Calgary, T2N 4N2
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Calgary, t2n42n
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Newmarket, L3Y2P9
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Ottawa, K1H 8L6
Germany4 sites
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Frankfurt am Main, 60431
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Freiburg im Breisgau, 79106
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Hamburg, 22087
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München, 81675
Australia3 sites
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Kurralta Park, 5037
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Nedlands, 6009
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St Leonards, 2065
Italy3 sites
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Genova, 16132
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Milan, 20132
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Sora, 03039
Mexico3 sites
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México, 03310
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México, 06700
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Mexico City, 14050
United Kingdom3 sites
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Leicester, LE1 5WN
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Manchester, M20 4BX
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Sutton, SM2 5PT
Greece2 sites
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Achaia, 26504
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Athens, 115 28
About this study
Official title: monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
- Being tested
- Abemaciclib, Trastuzumab, Fulvestrant, Standard of Care Single Agent Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called LY2835219
Administered Orally
TrastuzumabDrug
Administered IV
FulvestrantDrug
Administered IM
Standard of Care Single Agent ChemotherapyDrug
Standard-of-care single-agent chemotherapy of physician's choice administered according to product label
| Study group | Role | What they receive |
|---|---|---|
| 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant | Experimental | 150 milligram (mg) abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 milligram per kilogram (mg/kg) trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter. Receives: Drug: Abemaciclib; Drug: Trastuzumab; Drug: Fulvestrant |
| 150 mg Abemaciclib + 8 mg/kg Trastuzumab | Experimental | 150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle. Receives: Drug: Abemaciclib; Drug: Trastuzumab |
| 8 mg/kg Trastuzumab + Standard of Care Chemotherapy | Active comparator | 8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label Receives: Drug: Trastuzumab; Drug: Standard of Care Single Agent Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS time was measured from the date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, 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 first dose, 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.
Measured: Baseline to Progressive Disease or Death from Any Cause (Up To 36 Months)
Secondary outcomes (12)
Percentage of Participants With 1 Year Overall Survival (OS)
OS is defined as the time from the date of randomization until death from any cause. For participants not known to have died by the data-inclusion cutoff date, OS is censored at the last date they were known to be alive. For each treatment arm OS rate at 1 year from the date of randomization was determined using the OS times and was estimated using the Kaplan-Meier method.
Measured: Randomization to date of death from any cause assessed at 1 year
Percentage of Participants With 2 Year OS
OS is defined as the time from the date of randomization until death from any cause. For participants not known to have died by the data-inclusion cutoff date, OS is censored at the last date they were known to be alive. For each treatment arm OS rate at 2 years from the date of randomization was determined using the OS times and was estimated using the Kaplan-Meier method.
Measured: Randomization to date of death from any cause assessed at 2 years
Percentage of Participants With 3 Year OS
OS is defined as the time from the date of randomization until death from any cause. For participants not known to have died by the data-inclusion cutoff date, OS is censored at the last date they were known to be alive. For each treatment arm OS rate at 3 years from the date of randomization was determined using the OS times and was estimated using the Kaplan-Meier method.
Measured: Randomization to date of death from any cause assessed at 3 years
Percentage of Participants Achieving 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.
Measured: Baseline to Objective Disease Progression (Up To 36 Months)
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.
Measured: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up To 36 Months)
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (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.
Measured: Baseline to Objective Disease Progression (Up To 36 Months)
Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months: Clinical Benefit Rate (CBR)
Clinical benefit rate 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.
Measured: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Up To 36 Months)
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours and typical completion time for this instrument is less than 5 minutes. Mean Interference Score data is reported here. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Measured: Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
EORTC QLQ-C30 v3.0 was 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. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Measured: Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status.LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Measured: Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Measured: Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20)
Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20) was evaluated. M2 and M20 are 2 major active metabolites of abemaciclib.
Measured: Cycle(C)1 Day(D)1,C1D15, C2D1, C2D8, C3D1,C3D15, C4D1, C5D1:pre-dose; C1D1, C2D1, C3D1, C4D1, C5D1:post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start23 May 2016
- Primary completion8 Apr 2019
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hormone Receptor Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675231
- Sponsor's protocol ID
- 15804
- Other IDs
- I3Y-MC-JPBZ, 2015-003400-24, 2015
- Acronym
- monarcHER
- Status last verified
- Nov 2024
- First submitted
- 3 Feb 2016
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Publications
Tolaney SM, Goel S, Nadal J, Denys H, Borrego MR, Litchfield LM, Liu J, Appiah AK, Chen Y, Andre F. Overall Survival and Exploratory Biomarker Analyses of Abemaciclib plus Trastuzumab with or without Fulvestrant versus Trastuzumab plus Chemotherapy in HR+, HER2+ Metastatic Breast Cancer Patients. Clin Cancer Res. 2024 Jan 5;30(1):39-49. doi: 10.1158/1078-0432.CCR-23-1209.
PubMed 37906649Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, Ricci F, Im SA, Kim SB, Johnston SR, Chan A, Goel S, Catron K, Chapman SC, Price GL, Yang Z, Gainford MC, Andre F. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):763-775. doi: 10.1016/S1470-2045(20)30112-1. Epub 2020 Apr 27.
PubMed 32353342
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02675231
- Acronym / sponsor ID
- monarcHER / 15804
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 May 2016 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Posted 26 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant | Experimental | Drug: Abemaciclib, Drug: Trastuzumab, Drug: Fulvestrant150 milligram (mg) abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 milligram per kilogram (mg/kg) trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter. |
| 150 mg Abemaciclib + 8 mg/kg Trastuzumab | Experimental | Drug: Abemaciclib, Drug: Trastuzumab150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle. |
| 8 mg/kg Trastuzumab + Standard of Care Chemotherapy | Active comparator | Drug: Trastuzumab, Drug: Standard of Care Single Agent Chemotherapy8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- diagnosis of HR+, HER2+ breast cancer (BC)
- unresectable locally advanced recurrent BC or metastatic BC
- adequate tumor tissue available prior to randomization
- measurable and/or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- previously received:
Key exclusion criteria (12 listed)
- have visceral crisis
- known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms
- had major surgery within 14 days prior to randomization
- received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbemaciclibAlso: LY2835219Administered Orally | Drug | 150 mg Abemaciclib + 8 mg/kg Trastuzumab, 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant |
| TrastuzumabAdministered IV | Drug | 150 mg Abemaciclib + 8 mg/kg Trastuzumab, 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy |
| FulvestrantAdministered IM | Drug | 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant |
| Standard of Care Single Agent ChemotherapyStandard-of-care single-agent chemotherapy of physician's choice administered according to product label | Drug | 8 mg/kg Trastuzumab + Standard of Care Chemotherapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: Baseline to Progressive Disease or Death from Any Cause (Up To 36 Months)
PFS time was measured from the date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, 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 first dose, 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.
12 secondary outcomes
Percentage of Participants With 1 Year Overall Survival (OS)
Time frame: Randomization to date of death from any cause assessed at 1 year
Percentage of Participants With 2 Year OS
Time frame: Randomization to date of death from any cause assessed at 2 years
Percentage of Participants With 3 Year OS
Time frame: Randomization to date of death from any cause assessed at 3 years
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
Time frame: Baseline to Objective Disease Progression (Up To 36 Months)
Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up To 36 Months)
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
Time frame: Baseline to Objective Disease Progression (Up To 36 Months)
Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months: Clinical Benefit Rate (CBR)
Time frame: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Up To 36 Months)
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Time frame: Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Time frame: Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
Time frame: Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
Time frame: Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20)
Time frame: Cycle(C)1 Day(D)1,C1D15, C2D1, C2D8, C3D1,C3D15, C4D1, C5D1:pre-dose; C1D1, C2D1, C3D1, C4D1, C5D1:post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37906649Tolaney SM, Goel S, Nadal J, Denys H, Borrego MR, Litchfield LM, Liu J, Appiah AK, Chen Y, Andre F. Overall Survival and Exploratory Biomarker Analyses of Abemaciclib plus Trastuzumab with or without Fulvestrant versus Trastuzumab plus Chemotherapy in HR+, HER2+ Metastatic Breast Cancer Patients. Clin Cancer Res. 2024 Jan 5;30(1):39-49. doi: 10.1158/1078-0432.CCR-23-1209.
- Derived from this study: PubMed 32353342Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, Ricci F, Im SA, Kim SB, Johnston SR, Chan A, Goel S, Catron K, Chapman SC, Price GL, Yang Z, Gainford MC, Andre F. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):763-775. doi: 10.1016/S1470-2045(20)30112-1. Epub 2020 Apr 27.
- A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
93 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib, Trastuzumab and Fulvestrant in people with Hormone Receptor Positive Breast Cancer and HER-2 Positive Breast Cancer, run by Eli Lilly and Company at 93 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Argentina, France, South Korea, Brazil and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Baseline to Progressive Disease or Death from Any Cause (Up To 36 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675231, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.