NCT00925548

STRIDE - STimulating Immune Response In aDvanced brEast Cancer

A Randomized, Double-blind, Controlled Phase III Study of Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Combination With Hormonal Treatment Versus Hormonal Treatment Alone for First-line Therapy of Post-menopausal Women With Estrogen Receptor (ER)-Positive and/or Progesterone Receptor (PgR)-Positive, Inoperable Locally Advanced, Recurrent, or Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: EMD Serono · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of the study is to determine whether the addition of the experimental mucinous glycoprotein 1 (MUC1) antigen-specific cancer immunotherapy tecemotide (L-BLP25) to hormonal treatment is effective in prolonging progression-free survival in postmenopausal women with endocrine-sensitive inoperable locally advanced, recurrent or metastatic breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-06-22
• Last updated: 2014-07-24
• Results posted: 2014-07-24

Locations

29 sites across 12 countries: United States, Australia, Austria, Belgium, Czechia, Germany, Israel, Poland, Russia, Slovakia, South Africa, South Korea