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

NCT01990209 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-06-30

Study results available
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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.

Conditions

Interventions

DRUG

Orteronel

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Howard A Burris, III, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01990209 on ClinicalTrials.gov