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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038804
• Other study ID #: 155-CL-036
• Secondary ID: 2009-012439-14
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: September 12, 2013
• Start date: December 2009
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationIreland: Irish Medicines BoardCzech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• YM155
intravenous infusion
• Docetaxel
intravenous infusion

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet - Medical Oncology and Translational Research	Brussels
Belgium	Grand Hopital de Charleroi - Site Notre Dame	Charleroi
Belgium	Sint-Augustinus GZA Ziekenhuizen	Wilrijk
Czech Republic	Faculty Hospital Na Bulovce	Prague
Czech Republic	FN Kralovske Vinohrady	Prague 10
Germany	Hämatologisch-onkologische Praxis	Augsburg
Germany	Frauenklinik des Universitätsklinikums Erlangen	Erlangen
Germany	Universitatsklinikum Schleswig	Kiel
Germany	Klinikum Mutterhaus der Borromaeerinnen	Trier
Ireland	Department of Medical Oncology	Dublin
Ireland	St. James Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin
Poland	Centrum Onkologii-Instytut im.	Warsaw
Poland	Wojewodzki Szpital	Wroclaw
Russian Federation	State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary	Chelyabinsk
Russian Federation	State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"	Kursk
Russian Federation	Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre	Moscow
Russian Federation	Pyatigorsk Oncology Dispensary	Pyatigorsk
Russian Federation	Saint-Petersburg State Medical University named after Pavlov	Saint Petersburg
Russian Federation	Scientific-Research Institute of Oncology named after Petrov	Saint Petersburg
Russian Federation	State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"	Samara
Russian Federation	Tula Regional Dispensary	Tula
United Kingdom	Nottingham University Hospital	Nottingham
United States	Gabrail Cancer Center	Canton	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Carolina Oncology Specialists, PA	Hickory	North Carolina
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Kenmar Research Institute	Los Angeles	California
United States	Montana Cancer Institute Foundation c/o Montana Cancer Specialists	Missoula	Montana
United States	Bay Area Cancer Research Group	Pleasant Hill	California

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Germany,  Ireland,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		At the time of progression or death or at 2 year follow up	No
Secondary	Objective response rate (proportion of subjects with complete response or partial response)		At the time of progression or death or at 2 year follow up	No
Secondary	Overall survival		At the time of death or at 2 year follow up	No
Secondary	Duration of response		At the time of progression or at 2 year follow up	No
Secondary	Clinical benefit rate		At the time of progression or death or at 2 year follow up	No
Secondary	Time to response		At the time of response or at 2 year follow up	No
Secondary	Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)		Up to 30 days after last subject discontinues treatment	No