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NCT01990209 · ClinicalTrials.gov registry record · Phase 2
Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR)
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT01990209 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 71 participants.
The verdict
NCT01990209, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
The androgen receptor (AR) is expressed in 70-90 percent of primary breast tumors and in 75 percent of breast metastases. There is evidence to suggest that Androgen Receptor (AR) may be a target in patients with advanced breast cancer. Breast cancer patients whose tumors do not express the ER, PR or HER2 (triple negative) have very few options for treatment. Orteronel is being developed as an endocrine therapy for relevant hormone-sensitive cancers such as prostrate cancer and breast cancer. Triple-negative metastatic breast cancer patients with AR expression could potentially benefit from anti-androgen therapy like orteronel.
Interventions
- DRUG Orteronel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2014-03 |
| Est. Completion | 2021-05-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01990209
The ClinicalTrials.gov registry entry for NCT01990209 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Orteronel is the first listed.
NCT01990209 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01990209 about?
NCT01990209 is a clinical study titled "Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR)". The androgen receptor (AR) is expressed in 70-90 percent of primary breast tumors and in 75 percent of breast metastases. There is evidence to suggest that Androgen Receptor (AR) may be a target in patients with advanced breast cancer. Breast cancer patients whose tumors do not express the ER, PR or...
What is the current status of trial NCT01990209?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2014-03. Estimated completion is 2021-05-01.
What interventions are being tested in trial NCT01990209?
The interventions under investigation include: Orteronel (DRUG).
Who is sponsoring clinical trial NCT01990209?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
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