Trials / Completed
CompletedNCT03916744
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Giredestrant | 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). |
| PROCEDURE | Surgery | Breast cancer surgery will take place on Day 15 (+/-2 days). |
Timeline
- Start date
- 2019-07-26
- Primary completion
- 2021-05-25
- Completion
- 2021-05-25
- First posted
- 2019-04-16
- Last updated
- 2023-03-10
- Results posted
- 2023-03-10
Locations
15 sites across 5 countries: United States, Australia, Belgium, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03916744. Inclusion in this directory is not an endorsement.