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A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
NCT03004534 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03004534
The ClinicalTrials.gov registry entry for NCT03004534 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Translational Research in Oncology, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03004534 reports 14 study locations spanning 5 distinct geographic areas — top geographies include Quebec, California, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03004534?
The interventions under investigation include: darolutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03004534?
This trial is sponsored by Translational Research in Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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