Spots Global Cancer Trial Database for STRIDE - STimulating Immune Response In aDvanced brEast Cancer
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Trial Identification
Brief Title: STRIDE - STimulating Immune Response In aDvanced brEast Cancer
Official Title: 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
Study ID: NCT00925548
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Research Site, Hickory, North Carolina, United States
Research Site, Bedford Park, SA, , Australia
Research Site, Innsbruck, , Austria
Research Site, Salzburg, , Austria
Research Site, Leuven, , Belgium
Research Site, Pardubice, , Czech Republic
Research Site, Praha, , Czech Republic
Research Site, Chemnitz, , Germany
Research Site, Darmstadt, , Germany
Research Site, Frankfurt am Main, , Germany
Research Site, Hamburg, , Germany
Research Site, Kiel, , Germany
Research Site, Lübeck, , Germany
Research Site, München, , Germany
Research Site, Rostock, , Germany
Research Site, Tübingen, , Germany
Research Site, Wiesbaden, , Germany
Research Site, Beer Yaakov, , Israel
Research Site, Gyeonggi-do, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Opole, , Poland
Research Site, Obninsk, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Tula, , Russian Federation
Research Site, Bratislava, , Slovakia
Research Site, Nitra, , Slovakia
Research Site, Poprad, , Slovakia
Research Site, Trnava, , Slovakia
Research Site, Johannesburg, , South Africa
Contact Details
Name: Oscar Kashala, MD, PhD, DSc
Affiliation: EMD Serono
Role: STUDY_DIRECTOR
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