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.
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
Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
Diagnosis of inoperable locally advanced or Stage IV breast cancer
History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)
Planned surgery during the study
Single group
Giredestrant
DrugParticipants will receive giredestrant 30 mg orally once a day for up to 5 years.
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Incidence and Severity of Adverse Events (AEs)
Treatment Adherence, as Measured by Dose Intensity
Treatment Adherence, as Measured by Treatment Duration
Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)
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