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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01038804
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE December 22, 2009
First Posted Date  ICMJE December 24, 2009
Last Update Posted Date September 18, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2009)		 Progression free survival (PFS) [ Time Frame: At the time of progression or death or at 2 year follow up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
  • 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 ]
  • Overall survival [ Time Frame: 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 ]
  • Clinical benefit rate [ Time Frame: 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
Official Title  ICMJE A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: YM155
    intravenous infusion
  • Drug: Docetaxel
    intravenous infusion
    Other Name: Taxotere
Study Arms  ICMJE
  • Experimental: A. YM155 plus docetaxel
    Interventions:
    • Drug: YM155
    • Drug: Docetaxel
  • Active Comparator: B. docetaxel alone
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2011)		 101
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2009)		 180
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   Germany,   Ireland,   Poland,   Russian Federation,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01038804
Other Study ID Numbers  ICMJE 155-CL-036
2009-012439-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Astellas Pharma Inc
Original Responsible Party Sr. Manager Clinical Trials Registry, Astellas Pharma Global Development
Current Study Sponsor  ICMJE Astellas Pharma Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Astellas Pharma Inc
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP