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Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)

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.
 
ClinicalTrials.gov Identifier: NCT05169567
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Neoplasm Metastasis Drug: Abemaciclib Drug: Fulvestrant Drug: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
Actual Study Start Date : March 11, 2022
Estimated Primary Completion Date : August 4, 2023
Estimated Study Completion Date : February 16, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Abemaciclib plus Fulvestrant
Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).
 Drug: Abemaciclib
Administered orally.

Drug: Fulvestrant
Administered IM.
Active Comparator: Arm B: Placebo plus Fulvestrant
Placebo administered orally in combination with fulvestrant administered IM.
 Drug: Fulvestrant
Administered IM.

Drug: Placebo
Administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years) ]
    Investigator assessment


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization until death from any cause (estimated as up to 5 years) ]
    OS

  2. PFS [ Time Frame: Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years) ]
    Blinded independent review

  3. Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Randomization until measured progressive disease (estimated as up to 1 year) ]
    ORR

  4. Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks [ Time Frame: Randomization until measured progressive disease (estimated as up to 1 year) ]
    CBR

  5. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and stable disease (SD) [ Time Frame: Randomization until measured progressive disease (estimated as up to 1 year) ]
    DCR: Percentage of Participants with a Best Overall Response of CR, PR, and SD

  6. Duration of Response (DoR) [ Time Frame: Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years) ]
    DoR

  7. Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" [ Time Frame: Randomization through Follow-up (estimated as up to 3 years) ]
    The mBPI-sf "Worst pain" is a single self-reported item that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

  8. Time to Deterioration in Physical Function [ Time Frame: Randomization through Follow-up (estimated as up to 3 years) ]
    Physical Function scale includes five items (trouble with strenuous activities; trouble with long walk; trouble with short walk; need to stay in bed or chair; need help with eating, dressing, washing, toilet) in the European Organization for Research and Treatment of Cancer Item Library 19 (EORTC-19). Response options range from 0 ("not all") to 4 ("very much.") Higher composite scale scores indicate higher function.

  9. Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib [ Time Frame: Day 1 of Cycle 3 (Cycle = 28 days) ]
    PK: Mean Steady State Concentrations of Abemaciclib


Eligibility Criteria
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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.


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

Inclusion Criteria:

  • Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer

  • Have radiologic evidence of disease progression or recurrence either

    • On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
    • On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
  • Must be deemed appropriate for treatment with ET
  • If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
  • Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
  • Have adequate renal, hematologic, and hepatic organ function
  • Must be able to swallow capsules/tablets

Exclusion Criteria:

  • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
  • Have symptomatic or untreated central nervous system metastasis
  • Have received any systemic therapy between disease recurrence/progression and study screening
  • Have received more than 1 line of therapy for advanced or metastatic disease.
  • Have received prior chemotherapy for metastatic breast cancer (MBC)
  • Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor
Contacts and Locations
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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): NCT05169567


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Show Show 146 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05169567    
Other Study ID Numbers: 18238
I3Y-MC-JPEF ( Other Identifier: Eli Lilly and Company )
2021-002301-10 ( EudraCT Number )
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Breast Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
 Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs