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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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