CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
Orteroneldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01990209
NCT01990209Phase 2Completed

A Phase II Study With Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR)

SCRI Development Innovations, LLC·interventional·Posted Nov 21, 2013·Updated Jun 30, 2022

In Brief

A Phase 2 clinical trial evaluating Orteronel for Metastatic Breast Cancer. Completed, enrolled 71 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 21, 2013
Enrollment StartMar 1, 2014
Primary CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 12.6 years ago

Interventions

Orteroneldrug