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

Phase 2

Completed

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

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

Arm && Interventions

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

Locations (30): 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
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Kenmar Research Institute
🇺🇸Los Angeles, California, United States