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

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Lilly

Status and phase

Active, not recruiting
Phase 3

Conditions

Breast Neoplasm
Neoplasm Metastasis

Treatments

Drug: Fulvestrant
Drug: Placebo
Drug: Abemaciclib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05169567
18238
I3Y-MC-JPEF (Other Identifier)
2021-002301-10 (EudraCT Number)
2023-506771-10-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

368 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

368 participants in 2 patient groups

Arm A: Abemaciclib plus Fulvestrant
Experimental group
Description:
Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).
Treatment:
Drug: Abemaciclib
Drug: Fulvestrant
Arm B: Placebo plus Fulvestrant
Active Comparator group
Description:
Placebo administered orally in combination with fulvestrant administered IM.
Treatment:
Drug: Placebo
Drug: Fulvestrant

Trial contacts and locations

140

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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