The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.
Considered appropriate for treatment with endocrine therapy (ET)
Histologically confirmed diagnosis of ER+/HER2-, Stage I-III (low-/medium-/high-risk) early breast cancer (eBC)
Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive
Documented HER2- tumor according to ASCO/CAP
Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents
Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease
Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)
Have active cardiac disease or history of cardiac dysfunction
Single group
Giredestrant
DrugParticipants will receive giredestrant at a dose of 30 mg orally once daily on Days 1-28 of each 28-day cycle for up to 4.5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).
Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months
Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0)
Percentage of Participants Achieving an Improvement in Individual Endocrine Therapy-specific Symptoms at 6 and 12 Months, Using the FACT-ES Questionnaire
An improvement in individual endocrine therapy-specific symptoms (joint pain, hot flashes, vaginal dryness, and sexual dysfunction) is defined as ≥1-point/shift increase from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire items.
Percentage of Participants Categorized as Improved, Stable, or Worsening in Endocrine Therapy-specific Symptom Burden at 6 and 12 Months, Using the FACT-ES Questionnaire
Categories are defined by a change from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire Additional Concerns subscale score using a minimal important difference (MID) threshold of ±3 points.
Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-related Burden at 6 and 12 Months, Using the BPI-SF Questionnaire
Categories are defined by a change from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Pain Severity composite score (minimal important difference \[MID\] of ±2 points) and the BPI-SF Pain Interference composite score (MID of ±1 point).
Percentage of Participants Achieving an Improvement in Global Treatment Bother at 6 and 12 Months, Using the FACT-ES Questionnaire's GP5 Item
An improvement is defined as a ≥1-point increase from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) GP5 item ('I am bothered by side-effects of treatment').
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