Spots Global Cancer Trial Database for Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer
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Trial Identification
Brief Title: Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer
Official Title: Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")
Study ID: NCT00463788
Conditions
Study Description
Brief Summary: The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer. The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Research Site, Campbelltown, New South Wales, Australia
Research Site, Liverpool, New South Wales, Australia
Research Site, Wollongong, New South Wales, Australia
Research Site, Malvern, Victoria, Australia
Research Site, Perth, Western Australia, Australia
Research Site, Bludesch-Gais, , Austria
Research Site, Salzburg, , Austria
Research Site, Wien, , Austria
Research Site, Brussels, , Belgium
Research Site, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Liège, , Belgium
Research Site, Namur, , Belgium
Research Site, Wilrijk, , Belgium
Research Site, Frankfurt am Main, , Germany
Research Site, Heidelberg, , Germany
Research Site, Kiel, , Germany
Research Site, Köln, , Germany
Research Site, München, , Germany
Research Site, Rostock, , Germany
Research Site, Dublin, , Ireland
Research Site, Beer Sheba, , Israel
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Kefar Sava, , Israel
Research Site, Petah Tikva, , Israel
Research Site, Rehovot, , Israel
Research Site, Tel Aviv, , Israel
Research Site, Tel Hashomer, , Israel
Research Site, Genova, , Italy
Research Site, Modena, , Italy
Research Site, Christchurch, , New Zealand
Research Site, Wellington, , New Zealand
Research Site, Coimbra, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Murcia, , Spain
Research Site, Palma de Mallorca, , Spain
Research Site, Valencia, , Spain
Research Site, Zaragoza, , Spain
Research Site, Cardiff, , United Kingdom
Research Site, Guildford, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Contact Details
Name: José Baselga, Prof.
Affiliation: General Hospital, Boston, Massachusetts, USA
Role: PRINCIPAL_INVESTIGATOR
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