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A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

NCT01038804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2013-09-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.

Conditions

Interventions

DRUG

YM155

intravenous infusion

DRUG

Docetaxel

intravenous infusion

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Sr. Medical Director · Astellas Pharma Global Development

  • United Kingdom Principal Investigator · Royal Bournemouth Hospital

  • Poland Principal Investigator · Centrum Onkologii-Instytut im.

  • Ireland Principal Investigator · St Vincent's University Hospital

  • Germany Principal Investigator · Luisenkrankenhaus Duesseldorf

  • Czech Republic Principal Investigator · Thomayer Faculty Hosptial L.G.

  • Belgium Principal Investigator · Institut Jules Bordet - Medical Oncology and Translational Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • United States
  • Belgium
  • Czechia
  • Germany
  • Ireland
  • Poland
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01038804 on ClinicalTrials.gov