A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)
Sponsor: Genentech, Inc. • ClinicalTrials.gov ID: NCT07541079
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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.
Interventions
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Giredestrant
(Drug)
Participants 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).
Eligibility criteria
Conditions
Locations
- Orange Coast Medical Center — Fountain Valley, California, United States
- Stockton Hematology Oncology Medical Group-2626 N California St — Stockton, California, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Cancer and Leukemia Center — Sterling Heights, Michigan, United States
- Renown Health Conrad Breast Center at South Meadows — Reno, Nevada, United States
- Astera Cancer Care East Brunswick — East Brunswick, New Jersey, United States
- New York Oncology Hematology (Patroon) - USOR — Albany, New York, United States
- Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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