A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
- Registration Number
- NCT01038804
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A. YM155 plus docetaxel YM155 - A. YM155 plus docetaxel Docetaxel - B. docetaxel alone Docetaxel -
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) At the time of progression or death or at 2 year follow up
- Secondary Outcome Measures
Name Time Method Duration of response At the time of progression or at 2 year follow up Time to response 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) Up to 30 days after last subject discontinues treatment Overall survival At the time of death or at 2 year follow up Objective response rate (proportion of subjects with complete response or partial response) At the time of progression or death or at 2 year follow up Clinical benefit rate At the time of progression or death or at 2 year follow up
Trial Locations
- Locations (30)
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Sint-Augustinus GZA Ziekenhuizen
🇧🇪Wilrijk, Belgium
Bay Area Cancer Research Group
🇺🇸Pleasant Hill, California, United States
Kenmar Research Institute
🇺🇸Los Angeles, California, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Montana Cancer Institute Foundation c/o Montana Cancer Specialists
🇺🇸Missoula, Montana, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Institut Jules Bordet - Medical Oncology and Translational Research
🇧🇪Brussels, Belgium
Grand Hopital de Charleroi - Site Notre Dame
🇧🇪Charleroi, Belgium
Wojewodzki Szpital
🇵🇱Wroclaw, Poland
Faculty Hospital Na Bulovce
🇨🇿Prague, Czech Republic
FN Kralovske Vinohrady
🇨🇿Prague 10, Czech Republic
Frauenklinik des Universitätsklinikums Erlangen
🇩🇪Erlangen, Germany
Universitatsklinikum Schleswig
🇩🇪Kiel, Germany
Klinikum Mutterhaus der Borromaeerinnen
🇩🇪Trier, Germany
Hämatologisch-onkologische Praxis
🇩🇪Augsburg, Germany
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
St. James Hospital
🇮🇪Dublin, Ireland
Department of Medical Oncology
🇮🇪Dublin, Ireland
State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
🇷🇺Chelyabinsk, Russian Federation
Centrum Onkologii-Instytut im.
🇵🇱Warsaw, Poland
Pyatigorsk Oncology Dispensary
🇷🇺Pyatigorsk, Russian Federation
Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre
🇷🇺Moscow, Russian Federation
State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"
🇷🇺Samara, Russian Federation
Tula Regional Dispensary
🇷🇺Tula, Russian Federation
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
Scientific-Research Institute of Oncology named after Petrov
🇷🇺Saint Petersburg, Russian Federation
Carolina Oncology Specialists, PA
🇺🇸Hickory, North Carolina, United States
State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"
🇷🇺Kursk, Russian Federation
Saint-Petersburg State Medical University named after Pavlov
🇷🇺Saint Petersburg, Russian Federation