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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01038804
First received: December 22, 2009
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

Drug Information available for: Docetaxel
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: At the time of death or at 2 year follow up ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: At the time of progression or at 2 year follow up ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: At the time of progression or death or at 2 year follow up ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: At the time of response or at 2 year follow up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: December 2009
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038804

  Show 30 Study Locations
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01038804     History of Changes
Other Study ID Numbers: 155-CL-036, 2009-012439-14
Study First Received: December 22, 2009
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ireland: Irish Medicines Board
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Astellas Pharma Inc:
Breast Cancer
Metastatic
HER2 Negative
YM155

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013