NCT02675231

Brief 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 metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2016

Longer than P75 for phase_2

Geographic Reach
14 countries

93 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 23, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 26, 2020

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2023

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

2.9 years

First QC Date

February 3, 2016

Results QC Date

April 8, 2020

Last Update Submit

November 4, 2024

Conditions

Hormone Receptor Positive Breast CancerHER-2 Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    Randomization to date of death from any cause assessed at 1 year

  • Percentage of Participants With 2 Year OS

    Randomization to date of death from any cause assessed at 2 years

  • Percentage of Participants With 3 Year OS

    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)

    Baseline to Objective Disease Progression (Up To 36 Months)

  • Duration of Response (DoR)

    Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up To 36 Months)

  • +7 more secondary outcomes

Study Arms (3)

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.

Drug: AbemaciclibDrug: TrastuzumabDrug: 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.

Drug: AbemaciclibDrug: 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

Drug: TrastuzumabDrug: Standard of Care Single Agent Chemotherapy

Interventions

AbemaciclibDRUG

Administered Orally

Also known as: LY2835219
150 mg Abemaciclib + 8 mg/kg Trastuzumab150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant
TrastuzumabDRUG

Administered IV

150 mg Abemaciclib + 8 mg/kg Trastuzumab150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant8 mg/kg Trastuzumab + Standard of Care Chemotherapy
FulvestrantDRUG

Administered IM

150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant
Standard of Care Single Agent ChemotherapyDRUG

Standard-of-care single-agent chemotherapy of physician's choice administered according to product label

8 mg/kg Trastuzumab + Standard of Care Chemotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +2 more criteria

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (93)

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

St Jude Medical Center

Fullerton, California, 92835, United States

Location

TRIO - Translational Research in Oncology-US, Inc.

Los Angeles, California, 90024, United States

Location

USC Norris Cancer Hospital

Los Angeles, California, 90033, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Cancer Care Associates Medical Group

Redondo Beach, California, 90277, United States

Location

Central Coast Medical Oncology Corporation

Santa Monica, California, 93454, United States

Location

Catholic Health Initiatives (CHI)

Englewood, Colorado, 80112, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33908, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

University of Miami Plantation

Plantation, Florida, 33324, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Winship Cancer Center Emory University

Atlanta, Georgia, 30322, United States

Location

Northside Hospital Cancer Institute

Atlanta, Georgia, 30342, United States

Location

Fort Wayne Medical Oncology & Hematology, Inc.

Fort Wayne, Indiana, 46845, United States

Location

St Joseph Cancer Center

Lexington, Kentucky, 40509, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Billings Clinic Research Center

Billings, Montana, 59101, United States

Location

Brookdale Hospital Medical Center

Brooklyn, New York, 11212, United States

Location

North Shore Hematology Oncology Associates

East Setauket, New York, 11733, United States

Location

Clinical Research Alliance, Inc

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Northwest Medical Specialties, PLLC

Puyallup, Washington, 98372, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

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.

Buenos Aires, 1426, Argentina

Location

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CABA, 1025, Argentina

Location

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Córdoba, X5000JHGQ, Argentina

Location

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Córdoba, X5000JHQ, Argentina

Location

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La Rioja, 5300, Argentina

Location

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Rosario, 2000, Argentina

Location

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Rosario, S2000DSV, Argentina

Location

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San Miguel de Tucumán, T4000IAK, Argentina

Location

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Viedma, 8500, Argentina

Location

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Kurralta Park, 5037, Australia

Location

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Nedlands, 6009, Australia

Location

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St Leonards, 2065, Australia

Location

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Charleroi, 6000, Belgium

Location

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Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Leuven - Gasthuisberg

Leuven, 3000, Belgium

Location

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Namur, 5000, Belgium

Location

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Porto Alegre, 90610-000, Brazil

Location

Instituto COI de Pesquisa Educação e Gestão

Rio de Janeiro, 22793-080, Brazil

Location

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São Paulo, 01308-050, Brazil

Location

Fundação Antonio Prudente - Hospital do Câncer A.C Camargo

São Paulo, 01509-900, Brazil

Location

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São Paulo, 05651-901, Brazil

Location

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Calgary, T2N 4N2, Canada

Location

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Calgary, t2n42n, Canada

Location

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Newmarket, L3Y2P9, Canada

Location

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Ottawa, K1H 8L6, Canada

Location

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Angers, 49055, France

Location

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Besançon, 25030, France

Location

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Lyon, 69373, France

Location

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Montpellier, 34298, France

Location

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Nice, 06189, France

Location

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Paris, 75248, France

Location

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Saint-Cloud, 92210, France

Location

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Villejuif, 94805, France

Location

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Frankfurt am Main, 60431, Germany

Location

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Freiburg im Breisgau, 79106, Germany

Location

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Hamburg, 22087, Germany

Location

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München, 81675, Germany

Location

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Achaia, 26504, Greece

Location

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Athens, 115 28, Greece

Location

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Genova, 16132, Italy

Location

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Milan, 20132, Italy

Location

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Sora, 03039, Italy

Location

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Mexico City, 14050, Mexico

Location

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México, 03310, Mexico

Location

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México, 06700, Mexico

Location

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Daegu, 41404, South Korea

Location

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Goyang-si, 10408, South Korea

Location

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Seongnam-si, 13620, South Korea

Location

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Seoul, 02841, South Korea

Location

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Seoul, 03080, South Korea

Location

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Seoul, 03722, South Korea

Location

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Seoul, 05505, South Korea

Location

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Seoul, 06351, South Korea

Location

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Badajoz, 06080, Spain

Location

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Barcelona, 08035, Spain

Location

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Madrid, 28034, Spain

Location

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Madrid, 28040, Spain

Location

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Seville, 41013, Spain

Location

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Leicester, LE1 5WN, United Kingdom

Location

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Manchester, M20 4BX, United Kingdom

Location

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Sutton, SM2 5PT, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 37906649DERIVED

  • Tolaney 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.

    PMID: 32353342DERIVED

Related Links

MeSH Terms

Interventions

abemaciclibTrastuzumabFulvestrant

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 5, 2016

Study Start

May 23, 2016

Primary Completion

April 8, 2019

Study Completion

November 9, 2023

Last Updated

November 26, 2024

Results First Posted

May 26, 2020

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

AU(3)KR(8)ES(5)GB(3)BE(4)ME(3)US(32)DE(4)BR(5)AR(9)CA(4)GR(2)IT(3)FR(8)