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

Phase 3

Active, not recruiting

• Conditions: Neoplasm Metastasis; Breast Neoplasm
• Interventions: Drug: Abemaciclib; Drug: Fulvestrant; Drug: Placebo

• Registration Number: NCT05169567
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2021-12-27
• Study Start: 2022-03-11
• Primary Completion: 2024-02-08
• Results First Submitted: 2025-02-07
• Results First Submitted QC: 2025-02-07
• Results First Posted: 2025-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 368

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Abemaciclib plus Fulvestrant	Abemaciclib	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.
Arm A: Abemaciclib plus Fulvestrant	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.
Arm B: Placebo plus Fulvestrant	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.
Arm B: Placebo plus Fulvestrant	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)	PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 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 randomization, 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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)	Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months)	PFS is defined as the time from the date of randomization to the earliest date of disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
Objective Response Rate (ORR): Percentage of Participants Who Achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)	Randomization until measured progressive disease (Up to 22 Months)	ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

Trial Locations

Locations (133)

Regionshospitalet Gødstrup; 🇩🇰 Herning, Midtjylland, Denmark

Bacs-Kiskun Megyei Korhaz; 🇭🇺 Kecskemét, Bács-Kiskun, Hungary

Ankara Gülhane Eitim ve Aratrma Hastanesi; 🇹🇷 Ankara, Turkey

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Highlands Oncology Group; 🇺🇸 Springdale, Arkansas, United States

Providence Medical Foundation; 🇺🇸 Fullerton, California, United States

Cancer and Blood Specialty Clinic; 🇺🇸 Los Alamitos, California, United States

TRIO-US (Translational Research in Oncology-US); 🇺🇸 Los Angeles, California, United States

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States

UCLA Hematology/Oncology - Parkside; 🇺🇸 Santa Monica, California, United States

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