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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Docetaxel

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