Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: December 22, 2009
Last updated: September 12, 2013
Last verified: September 2013
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 Intervention Phase
Breast Cancer
Drug: YM155
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 101
Study Start Date: December 2009
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01038804

  Show 30 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
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
  More Information

Responsible Party: Astellas Pharma Inc Identifier: NCT01038804     History of Changes
Other Study ID Numbers: 155-CL-036
2009-012439-14 ( EudraCT Number )
Study First Received: December 22, 2009
Last Updated: September 12, 2013

Keywords provided by Astellas Pharma Inc:
Breast Cancer
HER2 Negative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017