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A Study of YM155 Plus Docetaxel in Subjects With HER2 Negative Metastatic Breast Cancer

2014-08-27 03:17:04 | BioPortfolio

Summary

The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

YM155, Docetaxel

Location

Mobile
Alabama
United States
36604

Status

Recruiting

Source

Astellas Pharma Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:04-0400

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