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Spots Global Cancer Trial Database for A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)

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Trial Identification

Brief Title: A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)

Official Title: A Multicenter, Phase III, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer

Study ID: NCT00262067

Study Description

Brief Summary: This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.

Detailed Description: This study includes a blinded treatment phase, an optional open-label post-progression phase, and a survival follow-up phase. During the blinded treatment phase, patients receive chemotherapy and study drug (bevacizumab or placebo) every 3 weeks until disease progression, treatment-limiting toxicity, or death due to any cause. The optional open-label post-progression phase consists of chemotherapy treatment (per investigator discretion) and optional treatment with open-label bevacizumab. Patients who complete the study or who discontinue from treatment (regardless of participation in the optional open-label post-progression phase) will be followed for survival and subsequent anti-cancer therapies every 4 months until death, withdrawal of consent, loss to follow-up, or study termination. Patients who discontinue from treatment during the blinded treatment phase for reasons other than disease progression will have tumor assessments every 9 weeks until documented disease progression or death.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Fullerton, California, United States

, Santa Barbara, California, United States

, Iowa City, Iowa, United States

, Sioux City, Iowa, United States

, Wichita, Kansas, United States

, Geelong, , Australia

, Malvern, , Australia

, Melbourne, , Australia

, Perth, , Australia

, Southport, , Australia

, Wahroonga, , Australia

, Waratah, , Australia

, Wollongong, , Australia

, Porto Alegre, , Brazil

, Rio de Janeiro, , Brazil

, Salvador, , Brazil

, Santo Andre, , Brazil

, Sao Paulo, , Brazil

, Winnipeg, Manitoba, Canada

, Montreal, Quebec, Canada

, Montreal, Quebec, Canada

, Marseille, , France

, Paris, , France

, Reims, , France

, Saint Herblain, , France

, Strasbourg, , France

, Athens, , Greece

, Hania, , Greece

, Heraklion, , Greece

, Patras, , Greece

, Thessaloniki, , Greece

, Guatemala City, , Guatemala

, Kyunggi-do, , Korea, Republic of

, Seoul, , Korea, Republic of

, Seoul, , Korea, Republic of

, Acapulco, , Mexico

, Aguascalientes, , Mexico

, Merida, , Mexico

, Monterrey, , Mexico

, Monterrey, , Mexico

, Amstelveen, , Netherlands

, Apeldoorn, , Netherlands

, Delft, , Netherlands

, Oslo, , Norway

, Oslo, , Norway

, Panama City, , Panama

, Callao, , Peru

, Quezon City, , Philippines

, Chelyabinsk, , Russian Federation

, Ivanovo, , Russian Federation

, Kazan, , Russian Federation

, Kazan, , Russian Federation

, Moscow, , Russian Federation

, Moscow, , Russian Federation

, Moscow, , Russian Federation

, Novosibirsk, , Russian Federation

, Obninsk, , Russian Federation

, Ryazan, , Russian Federation

, Samara, , Russian Federation

, St Petersburg, , Russian Federation

, UFA, , Russian Federation

, Singapore, , Singapore

, Singapore, , Singapore

, Córdoba, , Spain

, Elche, , Spain

, Girona, , Spain

, La Coruna, , Spain

, La Laguna, , Spain

, Madrid, , Spain

, Santander, , Spain

, Sevilla, , Spain

, Valencia, , Spain

, Zaragoza, , Spain

, Gaevle, , Sweden

, Uppsala, , Sweden

, Örebro, , Sweden

, Tainan, , Taiwan

, Taoyuan, , Taiwan

, Cherkassy, , Ukraine

, Dnipropetrovsk, , Ukraine

, Kiev, , Ukraine

, Lvov, , Ukraine

, Odessa, , Ukraine

, Zaporozhye, , Ukraine

, Chelsmford, , United Kingdom

, Cottingham, , United Kingdom

, Epping, , United Kingdom

, Huddersfield, , United Kingdom

, Nottingham, , United Kingdom

, Sheffield, , United Kingdom

, Swansea, , United Kingdom

, Montevideo, , Uruguay

Contact Details

Name: Leonardo Faoro, MD

Affiliation: Genentech, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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