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A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

This study is currently recruiting participants.
Verified October 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02675231
First Posted: February 5, 2016
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or 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.

Condition Intervention Phase
Hormone Receptor Positive Tumor HER-2 Positive Breast Cancer Drug: Abemaciclib Drug: Trastuzumab Drug: Fulvestrant Drug: Standard of Care Single Agent Chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated up to 24 Months) ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Estimated up to 48 Months) ]
  • Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) [ Time Frame: Baseline to Objective Disease Progression (Estimated up to 24 Months) ]
  • Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 24 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 (Estimated up to 24 Months) ]
  • Proportion 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 (Estimated up to 24 Months) ]
  • Change from Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) [ Time Frame: Baseline, up to 30 Days After Treatment Discontinuation (Estimated up to 24 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, up to 30 Days After Treatment Discontinuation (Estimated up to 24 Months) ]
  • Change from Baseline in Health Status on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, up to 30 Days After Treatment Discontinuation (Estimated up to 24 Months) ]
  • Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and its Metabolites, Fulvestrant, and Trastuzumab [ Time Frame: Predose Cycle 1 through Cycle 5 Day 1 (Approximately 4 Months) ]

Estimated Enrollment: 225
Study Start Date: March 2016
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abemaciclib + Trastuzumab + Fulvestrant
Abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a maintenance dose IV infusion on Day 1 of each subsequent cycle; plus fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.
Drug: Abemaciclib
Administered Orally
Other Name: LY2835219
Drug: Trastuzumab
Administered IV
Drug: Fulvestrant
Administered IM
Experimental: Abemaciclib + Trastuzumab
Abemaciclib given orally Q12H of a 21-day cycle; plus trastuzumab IV infusion on Day 1 of the cycle then a maintenance dose IV infusion on Day 1 of each subsequent cycle.
Drug: Abemaciclib
Administered Orally
Other Name: LY2835219
Drug: Trastuzumab
Administered IV
Active Comparator: Trastuzumab + Standard of Care Chemotherapy
Trastuzumab IV infusion on Day 1 of a 21-day cycle then a 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: Trastuzumab
Administered IV
Drug: Standard of Care Single Agent Chemotherapy
Standard-of-care single-agent chemotherapy of physician's choice administered according to product label

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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 id 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675231


Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 90 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02675231     History of Changes
Other Study ID Numbers: 15804
I3Y-MC-JPBZ ( Other Identifier: Eli Lilly and Company )
2015-003400-24 ( EudraCT Number )
First Submitted: February 3, 2016
First Posted: February 5, 2016
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Trastuzumab
Estradiol
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones