Barbara Ann Karmanos Cancer Institute | Detroit, MI
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About
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.
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Inclusion and exclusion criteria
Primary Study Inclusion Criteria:
Substudy Inclusion Criteria:
To be eligible for substudy participation, in addition to meeting the inclusion criteria in the primary protocol, participants must also meet the following modified criteria:
Primary Study Exclusion Criteria:
Substudy Exclusion Criteria:
Potential participants are excluded from the substudy if any criteria from t\he primary study or the following criteria apply:
Primary purpose
Allocation
Interventional model
Masking
4,200 participants in 3 patient groups
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Central trial contact
Reference Study ID Number: GO42784 https://forpatients.roche.com/
Data sourced from clinicaltrials.gov
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