At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 75 enrolled
Drug / intervention
Giredestrant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Multicenter, Open-Label Preoperative, Short-Term Window Study of GDC-9545 in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
In Brief
A Phase 1 clinical trial evaluating Giredestrant and Surgery for Breast Cancer. Completed, enrolled 75 participants across 15 sites in 5 countries.
Detailed Summary
This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Belgium, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartJul 2019
Primary CompletionMay 2021
TodayJul 2026
First PostedApr 16, 2019
Enrollment StartJul 26, 2019
Primary CompletionMay 25, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.2 years ago
Interventions
Giredestrantdrug
Giredestrant will be administered orally once daily (QD) starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15 (+/-2 days).
Surgeryprocedure
Breast cancer surgery will take place on Day 15 (+/-2 days).