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Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

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Trial Identification

Brief Title: A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

Official Title: A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy

Study ID: NCT00929240

Conditions

Breast Cancer

Study Description

Brief Summary: This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

, Fortaleza, CE, Brazil

, Belo Horizonte, MG, Brazil

, Rio de Janeiro, RJ, Brazil

, Ijui, RS, Brazil

, Porto Alegre, RS, Brazil

, Jau, SP, Brazil

, Santo Andre, SP, Brazil

, Sao Paulo, SP, Brazil

, Sao Paulo, SP, Brazil

, Beijing, , China

, Beijing, , China

, Beijing, , China

, Hangzhou, , China

, Hangzhou, , China

, Shanghai, , China

, Alexandria, , Egypt

, Cairo, , Egypt

, Amiens, , France

, Angers, , France

, Besancon, , France

, Bobigny, , France

, Dijon, , France

, Hyeres, , France

, Le Coudray, , France

, Lille, , France

, Paris, , France

, Paris, , France

, Perigueux, , France

, Rodez, , France

, St Priest En Jarez, , France

, Strasbourg, , France

, Hong Kong, , Hong Kong

, Hong Kong, , Hong Kong

, Bangalore, , India

, Hyderabad, , India

, Mumbai, , India

, Mumbai, , India

, New Delhi, , India

, New Delhi, , India

, Napoli, Campania, Italy

, Trieste, Friuli-Venezia Giulia, Italy

, Genova, Liguria, Italy

, Saronno, Lombardia, Italy

, Brindisi, Puglia, Italy

, Antella (FI), Toscana, Italy

, Bydgoszcz, , Poland

, Wroclaw, , Poland

, Dammam, , Saudi Arabia

, Jeddah, , Saudi Arabia

, Jeddah, , Saudi Arabia

, Alcoy, Alicante, Spain

, Sabadell, Barcelona, Barcelona, Spain

, Alcazar de S. Juan, Ciudad Real, Spain

, Barakaldo, Vizcaya, Spain

, Jaen, , Spain

, Malaga, , Spain

, Toledo, , Spain

, Valencia, , Spain

, Ankara, , Turkey

, Ankara, , Turkey

, Antalya, , Turkey

, Istanbul, , Turkey

, Sıhhiye, ANKARA, , Turkey

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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