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

NCT01038804 | Completed Phase 2

• 2 other identifiers: 155-CL-0362009-012439-14
• Study Type: interventional
• Target: 101
• Locations: 8 countries
• Sites: 30

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Metastatic; HER2 Negative; YM155

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

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

Secondary Outcomes (6)

• 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

• Overall survival

  At the time of death or at 2 year follow up

• Duration of response

  At the time of progression or at 2 year follow up

• Clinical benefit rate

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

• Time to response

  At the time of response or at 2 year follow up

Study Arms (2)

A. YM155 plus docetaxel

EXPERIMENTAL

Drug: YM155; Drug: Docetaxel

B. docetaxel alone

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

YM155 DRUG

intravenous infusion

A. YM155 plus docetaxel

Docetaxel DRUG

intravenous infusion

Also known as: Taxotere

A. YM155 plus docetaxel; B. docetaxel alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (30)

Kenmar Research Institute

Los Angeles, California, 90057, United States

Location

Bay Area Cancer Research Group

Pleasant Hill, California, 94523, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Montana Cancer Institute Foundation c/o Montana Cancer Specialists

Missoula, Montana, 59802, United States

Location

Carolina Oncology Specialists, PA

Hickory, North Carolina, 28602, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Institut Jules Bordet - Medical Oncology and Translational Research

Brussels, 1000, Belgium

Location

Grand Hopital de Charleroi - Site Notre Dame

Charleroi, 6000, Belgium

Location

Sint-Augustinus GZA Ziekenhuizen

Wilrijk, 2610, Belgium

Location

FN Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Faculty Hospital Na Bulovce

Prague, 180 81, Czechia

Location

Hämatologisch-onkologische Praxis

Augsburg, 86150, Germany

Location

Frauenklinik des Universitätsklinikums Erlangen

Erlangen, 91054, Germany

Location

Universitatsklinikum Schleswig

Kiel, 24105, Germany

Location

Klinikum Mutterhaus der Borromaeerinnen

Trier, 54290, Germany

Location

St. Vincent's University Hospital

Dublin, 4, Ireland

Location

St. James Hospital

Dublin, 8, Ireland

Location

Department of Medical Oncology

Dublin, 9, Ireland

Location

Centrum Onkologii-Instytut im.

Warsaw, 02-781, Poland

Location

Wojewodzki Szpital

Wroclaw, 51-124, Poland

Location

State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, 454076, Russia

Location

State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"

Kursk, 305035, Russia

Location

Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre

Moscow, 115478, Russia

Location

Pyatigorsk Oncology Dispensary

Pyatigorsk, 357500, Russia

Location

Scientific-Research Institute of Oncology named after Petrov

Saint Petersburg, 189646, Russia

Location

Saint-Petersburg State Medical University named after Pavlov

Saint Petersburg, 197022, Russia

Location

State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"

Samara, 443031, Russia

Location

Tula Regional Dispensary

Tula, 300053, Russia

Location

Nottingham University Hospital

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

sepantronium; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Sr. Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

• United Kingdom Principal Investigator

  Royal Bournemouth Hospital

  PRINCIPAL INVESTIGATOR

• Poland Principal Investigator

  Centrum Onkologii-Instytut im.

  PRINCIPAL INVESTIGATOR

• Ireland Principal Investigator

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

• Germany Principal Investigator

  Luisenkrankenhaus Duesseldorf

  PRINCIPAL INVESTIGATOR

• Czech Republic Principal Investigator

  Thomayer Faculty Hosptial L.G.

  PRINCIPAL INVESTIGATOR

• Belgium Principal Investigator

  Institut Jules Bordet - Medical Oncology and Translational Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

RU (8); GB (1); BE (3); IE (3); US (7); CZ (2); DE (4); PL (2)