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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01038804

Run by

Astellas Pharma Inc

People needed

101

Starts

2009-12-01

Expected to finish

2013-06-01

Last updated by the study team

2013-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kenmar Research Institute — Los Angeles, California, United States
• Bay Area Cancer Research Group — Pleasant Hill, California, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Montana Cancer Institute Foundation c/o Montana Cancer Specialists — Missoula, Montana, United States
• Carolina Oncology Specialists, PA — Hickory, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Institut Jules Bordet - Medical Oncology and Translational Research — Brussels, Belgium
• Grand Hopital de Charleroi - Site Notre Dame — Charleroi, Belgium
• Sint-Augustinus GZA Ziekenhuizen — Wilrijk, Belgium
• FN Kralovske Vinohrady — Prague, Czechia
• Faculty Hospital Na Bulovce — Prague, Czechia
• Hämatologisch-onkologische Praxis — Augsburg, Germany
• Frauenklinik des Universitätsklinikums Erlangen — Erlangen, Germany
• Universitatsklinikum Schleswig — Kiel, Germany
• Klinikum Mutterhaus der Borromaeerinnen — Trier, Germany
• St. Vincent's University Hospital — Dublin, Ireland
• St. James Hospital — Dublin, Ireland
• Department of Medical Oncology — Dublin, Ireland
• Centrum Onkologii-Instytut im. — Warsaw, Poland
• Wojewodzki Szpital — Wroclaw, Poland
• State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary — Chelyabinsk, Russia
• State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD" — Kursk, Russia
• Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre — Moscow, Russia
• Pyatigorsk Oncology Dispensary — Pyatigorsk, Russia

Full record on ClinicalTrials.gov

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