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STRIDE - STimulating Immune Response In aDvanced brEast Cancer

NCT00925548 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-07-24

Study results available
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Summary

EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Oscar Kashala, MD, PhD, DSc · EMD Serono

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Germany
  • Israel
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925548 on ClinicalTrials.gov