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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: YM155
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A. YM155 plus docetaxel<br> | Drug: YM155<br>* intravenous infusion<br>Drug: Docetaxel<br>* intravenous infusion<br>* Other names: Taxotere;|
| Active Comparator: B. docetaxel alone<br> | Drug: Docetaxel<br>* intravenous infusion<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | At the time of progression or death or at 2 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall survival |  | At the time of death or at 2 year follow up | 
| Duration of response |  | At the time of progression or at 2 year follow up | 
| Clinical benefit rate |  | At the time of progression or death 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Metastatic, HER2 Negative, YM155