Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 14, 2026
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Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT02107703). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 669 participants (ACTUAL). Conditions: Breast Neoplasms. Interventions: DRUG: Abemaciclib; DRUG: Fulvestrant; DRUG: Placebo. Primary outcome measures: Progression-Free Survival (PFS) , From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months). Brief summary: The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.