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

Astellas

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Docetaxel

Drug: YM155

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038804

155-CL-036

2009-012439-14 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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