Clinical trial NCT01038804: A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Metastatic
HER2 Negative
YM155
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-12-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: At the time of progression or death or at 2 year follow up
Secondary outcomes:
measure: Objective response rate (proportion of subjects with complete response or partial response)
timeFrame: At the time of progression or death or at 2 year follow up
measure: Overall survival
timeFrame: At the time of death or at 2 year follow up
measure: Duration of response
timeFrame: At the time of progression or at 2 year follow up
measure: Clinical benefit rate
timeFrame: At the time of progression or death or at 2 year follow up
measure: Time to response
timeFrame: At the time of response or at 2 year follow up
measure: Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
timeFrame: Up to 30 days after last subject discontinues treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kenmar Research Institute
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Missoula
country: United States
facility: Montana Cancer Institute Foundation c/o Montana Cancer Specialists
state: Montana
city: Hickory
country: United States
facility: Carolina Oncology Specialists, PA
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Brussels
country: Belgium
facility: Institut Jules Bordet - Medical Oncology and Translational Research
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi - Site Notre Dame
city: Wilrijk
country: Belgium
facility: Sint-Augustinus GZA Ziekenhuizen
city: Prague 10
country: Czech Republic
facility: FN Kralovske Vinohrady
city: Prague
country: Czech Republic
facility: Faculty Hospital Na Bulovce
city: Augsburg
country: Germany
facility: Hämatologisch-onkologische Praxis
city: Erlangen
country: Germany
facility: Frauenklinik des Universitätsklinikums Erlangen
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromaeerinnen
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
city: Dublin
country: Ireland
facility: St. James Hospital
city: Dublin
country: Ireland
facility: Department of Medical Oncology
city: Warsaw
country: Poland
facility: Centrum Onkologii-Instytut im.
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital
city: Chelyabinsk
country: Russian Federation
facility: State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
city: Kursk
country: Russian Federation
facility: State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"
city: Moscow
country: Russian Federation
facility: Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Scientific-Research Institute of Oncology named after Petrov
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical University named after Pavlov
city: Samara
country: Russian Federation
facility: State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"
city: Tula
country: Russian Federation
facility: Tula Regional Dispensary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
Study officials:
affiliation: Astellas Pharma Global Development
name: Sr. Medical Director
role: STUDY_DIRECTOR
affiliation: Royal Bournemouth Hospital
name: United Kingdom Principal Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Centrum Onkologii-Instytut im.
name: Poland Principal Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's University Hospital
name: Ireland Principal Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Luisenkrankenhaus Duesseldorf
name: Germany Principal Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomayer Faculty Hosptial L.G.
name: Czech Republic Principal Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Jules Bordet - Medical Oncology and Translational Research
name: Belgium Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: