About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Giredestrant