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

September 12, 2013 updated by: Astellas Pharma Inc

A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an outpatient study. All subjects enrolled in this study will receive a combined regimen of YM155 and docetaxel or docetaxel alone given during 21 day cycles. Each subject will be assessed at the end of each cycle to determine if the subject can continue to the next cycle. Each subject assigned to receive YM155 in combination with docetaxel will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.

If a subject discontinues treatment with at least stable disease (SD) that subject will complete follow-up visits every 12 weeks for 2 years or until initiating another systemic anti-breast cancer treatment, exhibiting progressive disease (PD), or death.

Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 2 years.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet - Medical Oncology and Translational Research
      • Charleroi, Belgium, 6000
        • Grand Hôpital de Charleroi - Site Notre Dame
      • Wilrijk, Belgium, 2610
        • Sint-Augustinus GZA Ziekenhuizen
  • Czech Republic
      • Prague, Czech Republic, 180 81
        • Faculty hospital Na Bulovce
      • Prague 10, Czech Republic, 100 34
        • FN Kralovske Vinohrady
  • Germany
      • Augsburg, Germany, 86150
        • Hämatologisch-Onkologische Praxis
      • Erlangen, Germany, 91054
        • Frauenklinik des Universitätsklinikums Erlangen
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig
      • Trier, Germany, 54290
        • Klinikum Mutterhaus der Borromaeerinnen
  • Ireland
      • Dublin, Ireland, 8
        • St. James Hospital
      • Dublin, Ireland, 4
        • St. Vincent's University Hospital
      • Dublin, Ireland, 9
        • Department of Medical Oncology
  • Poland
      • Warsaw, Poland, 02-781
        • Centrum Onkologii-Instytut im.
      • Wroclaw, Poland, 51-124
        • Wojewodzki Szpital
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454076
        • State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
      • Kursk, Russian Federation, 305035
        • State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"
      • Moscow, Russian Federation, 115478
        • Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre
      • Pyatigorsk, Russian Federation, 357500
        • Pyatigorsk Oncology Dispensary
      • Saint Petersburg, Russian Federation, 189646
        • Scientific-Research Institute of Oncology named after Petrov
      • Saint Petersburg, Russian Federation, 197022
        • Saint-Petersburg State Medical University named after Pavlov
      • Samara, Russian Federation, 443031
        • State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"
      • Tula, Russian Federation, 300053
        • Tula Regional Dispensary
  • United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
      • Pleasant Hill, California, United States, 94523
        • Bay Area Cancer Research Group
    • Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Montana
      • Missoula, Montana, United States, 59802
        • Montana Cancer Institute Foundation c/o Montana Cancer Specialists
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Carolina Oncology Specialists, PA
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible
  • No prior chemotherapy regimen for metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit
  • The subject's life expectancy is estimated to be > 12 weeks at the Baseline Visit
  • The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period

Exclusion Criteria:

  • Hypersensitivity to docetaxel or polysorbate 80
  • Neuropathy ≥ Grade 2 at the Baseline Visit
  • Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
  • The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A. YM155 plus docetaxel
Drug: YM155
intravenous infusion
Drug: Docetaxel
intravenous infusion
Other Names:
  • Taxotere
Active Comparator: B. docetaxel alone
Drug: Docetaxel
intravenous infusion
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: At the time of progression or death or at 2 year follow up
At the time of progression or death or at 2 year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (proportion of subjects with complete response or partial response)
Time Frame: At the time of progression or death or at 2 year follow up
At the time of progression or death or at 2 year follow up
Overall survival
Time Frame: At the time of death or at 2 year follow up
At the time of death or at 2 year follow up
Duration of response
Time Frame: At the time of progression or at 2 year follow up
At the time of progression or at 2 year follow up
Clinical benefit rate
Time Frame: At the time of progression or death or at 2 year follow up
At the time of progression or death or at 2 year follow up
Time to response
Time Frame: At the time of response or at 2 year follow up
At the time of response or at 2 year follow up
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time Frame: Up to 30 days after last subject discontinues treatment
Up to 30 days after last subject discontinues treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Sr. Medical Director, Astellas Pharma Global Development
  • Principal Investigator: United Kingdom Principal Investigator, Royal Bournemouth Hospital
  • Principal Investigator: Poland Principal Investigator, Centrum Onkologii-Instytut im.
  • Principal Investigator: Ireland Principal Investigator, St. Vincent's University Hospital
  • Principal Investigator: Germany Principal Investigator, Luisenkrankenhaus Duesseldorf
  • Principal Investigator: Czech Republic Principal Investigator, Thomayer Faculty Hosptial L.G.
  • Principal Investigator: Belgium Principal Investigator, Institut Jules Bordet - Medical Oncology and Translational Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 155-CL-036
  • 2009-012439-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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