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A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide

NCT03004534 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-04-03

Study results available
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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

  • Breast Cancer Female

Interventions

DRUG

darolutamide

Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Translational Research in Oncology

    lead OTHER

Principal Investigators

  • Rodrigo Fresco, MD · Translational Research in Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2019-02-14
Completion
2019-03-13
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03004534 on ClinicalTrials.gov