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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,500
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Time frame: Month 12
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to approximately 5 years
Treatment Adherence, as Measured by Dose Intensity
Time frame: Up to approximately 5 years
Treatment Adherence, as Measured by Treatment Duration
Time frame: Up to approximately 5 years
Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for the Overall Endocrine Symptom Burden as Assessed by FACT-ES Endocrine Symptom Subscale Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in the Overall Endocrine Symptom Burden Score as Assessed by FACT-ES Endocrine Symptom Subscale Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Pain as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Composite Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Pain as Assessed by the BPI-SF Pain Severity Composite Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Percentage of Participants Reporting Each Response Option for the Treatment Side-Effect Bother Single-Item GP5 (General Physical Well-Being Item 5) as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Change From Baseline in the Treatment Side-Effect Bother Single-Item GP5 as Assessed by FACT-G
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort B: Percentage of Participants Achieving Improvement in Joint Pain Score as Assessed by FACT-ES
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Endocrine Therapy-Specific Symptom Burden as Assessed by the FACT-ES Endocrine Symptom Subscale Score
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Severity Composite Score
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Interference Composite Score
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Global Treatment Bother as Assessed by the Single-Item GP5 From the FACT-G
Time frame: Month 6 and Month 12
Cohort A: Mean Absolute Score for Physical Function as Assessed by the European Organization for Research and Treatment of Cancer Item Library 492 (EORTC IL 492)
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Physical Function Score as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Role Function Score as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Cognitive Function Score as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Health-Related Quality of Life (HRQoL) as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Physical Function as Assessed by EORTC IL 492
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Role Function as Assessed by EORTC IL 492
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Cognitive Function as Assessed by EORTC IL 492 Subscale Score
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in HRQoL as Assessed by EORTC IL 492 Subscale Score
Time frame: Month 6 and Month 12
Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.
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