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NCT03004534 · ClinicalTrials.gov registry record · Early Phase 1
A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
A Early Phase 1 study of Breast Cancer Female, sponsored by Translational Research in Oncology.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 36
- Enrollment target
- 14
- Study locations
NCT03004534: Completed Early Phase 1 study of Breast Cancer Female, sponsored by Translational Research in Oncology.
NCT03004534 is a Early Phase 1 study of Breast Cancer Female that has completed, run by Translational Research in Oncology. The registered enrollment target is 36 participants, below the 692-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (95% lower). The trial reports 14 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03004534, a Early Phase 1 study of Breast Cancer Female, has completed, sponsored by Translational Research in Oncology.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 36 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects. The intent is to study these changes in order to have a better understanding of the potential use of darolutamide for women with EBC, know which patients are likely or unlikely to respond to this treatment, and determine how darolutamide may be combined with other anti-cancer drugs.
Primary Outcome
Androgen Receptor (AR) was assessed on the collected samples.
Conditions Studied
Interventions
- DRUG darolutamide
Study Locations (14)
Quebec
- (CIUSSS) de l'Est-de-l'Île-de-Montréal - l'Hôpital Maisonneuve-Rosemont - Montreal
- Centre Hospitalier de l'Université de Montréal (CHUM) - Montreal
- Jewish General Hospital - Montreal
- McGill University Hospital - Montreal
- Centre Hospitalier Affilie Universitaire De Quebec - Hospital Du Saint-Sacrement - Québec
California
- UCLA - Los Angeles
- Valley Breast Care and Women's Health Center - Los Angeles
- Torrance Memorial Physician Network, Cancer Care Associates - Redondo Beach
- Central Coast Medical Oncology - Santa Maria
Other
- Universitatsklinikum Erlangen - Erlangen
- Interdisziplinares Onkologisches Zentrum - München
- Department of Women's Health - Tübingen
Florida
- UF Health Cancer Center - Orlando Health - Orlando
Alberta
- Cross Cancer Institute - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-09-05 |
| Est. Completion | 2019-03-13 |
| Phase | Early Phase 1 |
What the finished NCT03004534 record still lists
NCT03004534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 692-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Breast Cancer Female appearing as the primary indexed condition, and to 1 intervention - of which darolutamide is the first listed.
NCT03004534 lists 14 locations in 5 states (Quebec, California, Other).
Frequently Asked Questions
What is clinical trial NCT03004534 about?
NCT03004534 is a clinical study titled "A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide". The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects. The intent is to study these cha...
What is the current status of trial NCT03004534?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2017-09-05. Estimated completion is 2019-03-13.
What conditions does trial NCT03004534 study?
This clinical trial studies the following conditions: Breast Cancer Female.
What interventions are being tested in trial NCT03004534?
The interventions under investigation include: darolutamide (DRUG).
Who is sponsoring clinical trial NCT03004534?
This trial is sponsored by Translational Research in Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03004534 being conducted?
This trial has 14 study locations across California, Florida, Alberta, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer Female
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03004534's enrollment target sits among peer trials
36 37th of 46 higher than 10 of 46 other Breast Cancer Female trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Female 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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