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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

At the time of progression or death or at 2 year follow up

Safety Issue:

No

Principal Investigator

Sr. Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

155-CL-036

NCT ID:

NCT01038804

Start Date:

December 2009

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Metastatic
  • HER2 Negative
  • YM155
  • Breast Neoplasms

Name

Location

Kenmar Research InstituteLos Angeles, California  90057
Lakeland Regional Cancer CenterLakeland, Florida  33805
Gabrail Cancer CenterCanton, Ohio  44718
Bay Area Cancer Research GroupConcord, California  94520
Karmanos Cancer InstituteDetroit, Michigan  48201
Montana Cancer Institute Foundation c/o Montana Cancer SpecialistsMissoula, Montana  59802
Carolina Oncology Specialists, PAHickory, North Carolina  28602