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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
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: YM155 Drug: Docetaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
Study Start Date : December 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: A. YM155 plus docetaxel Drug: YM155
intravenous infusion

Drug: Docetaxel
intravenous infusion
Other Name: Taxotere

Active Comparator: B. docetaxel alone Drug: Docetaxel
intravenous infusion
Other Name: Taxotere

Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: At the time of progression or death or at 2 year follow up ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall survival [ Time Frame: At the time of death or at 2 year follow up ]
  3. Duration of response [ Time Frame: At the time of progression or at 2 year follow up ]
  4. Clinical benefit rate [ Time Frame: At the time of progression or death or at 2 year follow up ]
  5. Time to response [ Time Frame: At the time of response or at 2 year follow up ]
  6. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038804

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Sponsors and Collaborators
Astellas Pharma Inc
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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
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01038804    
Other Study ID Numbers: 155-CL-036
2009-012439-14 ( EudraCT Number )
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013
Keywords provided by Astellas Pharma Inc:
Breast Cancer
HER2 Negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action