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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
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 (NCT07890597). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 3800 participants (ESTIMATED). Conditions: Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-). Interventions: DRUG: Atirmociclib; DRUG: giredestrant; OTHER: Atirmociclib placebo. Primary outcome measures: Invasive Breast Cancer Free Survival (iBCFS) , Baseline until recurrence up to 64 months; Invasive Disease Free Survival (iDFS) , Baseline until recurrence up to 64 months. Brief summary: This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or high risk of recurrence. This is a Phase 3, double blind, placebo controlled study of atirmociclib plus giredestrant vs. giredestrant monotherapy as adjuvant treatment in adult patients with ER+, HER2- early breast cancer. The study plans to enroll 3800 participants randomized 1:1 into one of two treatment arms (Arm A - investigational: atirmociclib plus giredestrant taken continuously in a 28-day cycle) or (Arm B - comparator: placebo plus giredestrant taken continuously in a 28-day cycle). Participants may be treated with atirmociclib/placebo up to 3 years and giredestrant up to 5 years followed by long term follow up for survival and evaluation of recurrence of disease.