Hoffmann-La Roche
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.
Inclusion Criteria: * Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer * Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy) * Participants must have completed any prior adjuvant chemotherapy before enrollment, if given * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2 * Adequate organ function * Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist Exclusion Criteria: * Pregn…
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.