STRIDE - STimulating Immune Response In aDvanced brEast Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Tecemotide (L-BLP25) and Hormonal Treatment

"Investigational Arm:~Pretreatment (Single Dose) 300 mg/m\^2 of intravenous cyclophosphamide in investigational arm to a maximum of 600 milligrams (mg).~Primary treatment phase:~Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)\* (Week 1 to 8).~Maintenance treatment phase:~Hormonal treatment plus vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)\* at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD).~\*calculated as mass of lipopeptide (antigen)"

BIOLOGICAL

Placebo of tecemotide (L-BLP25) and Hormonal Treatment

"Control Arm:~Pretreatment (Single Dose) NaCl 9 g/L infusion as a substitute for cyclophosphamide.~Primary treatment phase:~Hormonal therapy plus 8 consecutive weekly subcutaneous placebo doses (Week 1 to 8).~Maintenance treatment phase:~Hormonal therapy plus placebo doses at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD)."

DRUG

cyclophosphamide

300 mg/m\^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.

DRUG

sodium chloride (NaCl)

NaCl 9 g/L infusion

Trial Locations (29)

Unknown

Research Site, Hickory

Research Site, Bedford Park, SA

Research Site, Innsbruck

Research Site, Salzburg

Research Site, Leuven

Research Site, Pardubice

Research Site, Prague

Research Site, Chemnitz

Research Site, Darmstadt

Research Site, Frankfurt am Main

Research Site, Hamburg

Research Site, Kiel

Research Site, Lübeck

Research Site, München

Research Site, Rostock

Research Site, Tübingen

Research Site, Wiesbaden

Research Site, Beer Yaakov

Research Site, Opole

Research Site, Obninsk

Research Site, Saint Petersburg

Research Site, Tula

Research Site, Bratislava

Research Site, Nitra

Research Site, Poprad

Research Site, Trnava

Research Site, Johannesburg

Research Site, Gyeonggi-do

Research Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT00925548 - STRIDE - STimulating Immune Response In aDvanced brEast Cancer | Biotech Hunter | Biotech Hunter