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NCT03916744 · ClinicalTrials.gov registry record · Phase 1
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 15
- Study locations
NCT03916744: Completed Phase 1 study of Breast Cancer, sponsored by Genentech.
NCT03916744 is a Phase 1 study of Breast Cancer that has completed, run by Genentech. The registered enrollment target is 75 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03916744, a Phase 1 study of Breast Cancer, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the proportion of nuclei staining Ki67-positive (Ki67+) in the tumor biopsy sample taken post-treatment (at surgery) relative to that in the pre-treatment
Conditions Studied
Interventions
- PROCEDURE Surgery
- DRUG Giredestrant
Study Locations (15)
Other
- Clinique Edith Cavell; Pharmacie - Auderghem
- UZ Antwerpen - Edegem
- Clinique Sainte-Elisabeth; Oncologie - Namur
- Hospital Universitari Vall d'Hebron - Barcelona
- Hospital Ruber Internacional;Servicio de Oncologia - Madrid
- HM Sanchinarro ? CIOCC - Madrid
- Hospital Clinico Universitario de Valencia - Valencia
- Barts Health NHS Trust; William Harvey Heart Centre, QMUL School of Medicine & Dentistry - London
- Royal Cornwall Hospital - Truro
Colorado
- University of Colorado - Aurora
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
New South Wales
- St Vincent's Hospital Sydney - Darlinghurst
Victoria
- Sunshine Hospital - St Albans
Guipuzcoa
- Onkologikoa - Instituto Oncológico de Donostia - Donostia / San Sebastian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-07-26 |
| Est. Completion | 2021-05-25 |
| Phase | Phase 1 |
What the finished NCT03916744 record still lists
NCT03916744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Surgery is the first listed.
NCT03916744 lists 15 locations in 7 states (Other, Colorado, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03916744 about?
NCT03916744 is a clinical study titled "A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer". 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.
What is the current status of trial NCT03916744?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2019-07-26. Estimated completion is 2021-05-25.
What conditions does trial NCT03916744 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03916744?
The interventions under investigation include: Surgery (PROCEDURE), Giredestrant (DRUG).
Who is sponsoring clinical trial NCT03916744?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03916744 being conducted?
This trial has 15 study locations across Colorado, Massachusetts, New York, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03916744's enrollment target sits among peer trials
75 675th of 1224 higher than 544 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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