Trial | NCT01038804  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    101
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.
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.
Study Started
Dec 31
2009
Primary Completion
Jun 30
2012
Study Completion
Jun 30
2013
Last Update
Sep 18
2013
Estimate

Drug YM155

intravenous infusion

Drug Docetaxel

intravenous infusion

  • Other names: Taxotere

A. YM155 plus docetaxel Experimental

B. docetaxel alone Active Comparator

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
No Results Posted