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

Purpose

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.

Conditions

  • Breast Neoplasm
  • Neoplasm Metastasis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Abemaciclib plus Fulvestrant 		Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
  • Drug: Abemaciclib
    Administered orally.
  • Drug: Fulvestrant
    Administered IM.
Active Comparator
Arm B: Placebo plus Fulvestrant 		Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
  • Drug: Fulvestrant
    Administered IM.
  • Drug: Placebo
    Administered orally.

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Study Contact