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A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment

Study acronym: kalitERA
StatusNot Yet Recruiting
PhasePhase 3
Started2026-10-30
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364 trials monitored
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5,180 trials monitored
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The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant. The study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.
Trial Details
NCT Number NCT07827573
Lead Sponsor Hoffmann-La Roche
Conditions Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
Enrollment 1,500 participants
Start Date 2026-10-30
Primary Completion 2028-11-30 (estimated)
Study Completion 2032-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-18