Study of Giredestrant Treatment and Patient Experience in Women With Early ERHER2- Breast Cancer Who Cannot Tolerate Aromatase Inhibitors

What this Trial Is About

Researchers are evaluating the use of giredestrant as an adjuvant endocrine therapy for female participants with estrogen receptor positive ER, human epidermal growth factor receptor 2 negative HER2- early breast cancer Stages I-III who have shown intolerance to prior aromatase inhibitor AI treatments. This Phase IIIb, single-arm, open-label study aims to understand treatment adherence and patient-reported outcomes among participants switching to giredestrant due to AI intolerance. Participants are classified by risk levels and must have histologically confirmed cancer as defined by the investigator. Participants will receive giredestrant orally at a dose of 30 mg once daily on Days 1-28 of each 28-day cycle. Treatment can continue for up to 4.5 years or until disease recurrence or unacceptable toxicity occurs, whichever happens first. Giredestrant is given as a single experimental treatment without a comparator or placebo group in this study. During the study, participants will be monitored for treatment adherence, tolerability, and patient-reported outcomes through questionnaires such as FACT-ES and BPI-SF at baseline, 6 months, and 12 months. Researchers will also assess adverse events from baseline until 28 days after the last dose. The primary outcome includes the incidence of treatment discontinuation at 12 months. The study will continue for several years, with regular assessments to evaluate safety and symptom changes throughout the treatment period.

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)