Breast Cancer Clinical Trial

Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Summary

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

View Eligibility Criteria

Eligibility Criteria

Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
Patients must be resistant to taxane therapy.
Patients may not have any history of brain and/or leptomeningeal metastases.
Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

752

Study ID:

NCT00080301

Recruitment Status:

Completed

Sponsor:

R-Pharm

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There is 1 Location for this study

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Little Rock Arkansas, , United States
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San Francisco California, , United States
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Vallejo California, , United States
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Denver Colorado, , United States
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Hartford Connecticut, , United States
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Washington District of Columbia, , United States
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Orlando Florida, , United States
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Baltimore Maryland, , United States
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Burlington Massachusetts, , United States
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Jackson Mississippi, , United States
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Columbia Missouri, , United States
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Kansas City Missouri, , United States
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Saint Louis Missouri, , United States
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Omaha Nebraska, , United States
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Livingston New Jersey, , United States
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New Brunswick New Jersey, , United States
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Albuquerque New Mexico, , United States
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New York New York, , United States
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Columbus Ohio, , United States
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Oklahoma City Oklahoma, , United States
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Tulsa Oklahoma, , United States
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Pittsburgh Pennsylvania, , United States
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Columbia South Carolina, , United States
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Greenville South Carolina, , United States
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Knoxville Tennessee, , United States
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Nashville Tennessee, , United States
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Austin Texas, , United States
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Houston Texas, , United States
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Ogden Utah, , United States
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Burlington Vermont, , United States
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Tacoma Washington, , United States
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Morgantown West Virginia, , United States
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Capital Federal Buenos Aires, , Argentina
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Haedo Buenos Aires, , Argentina
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La Plata Buenos Aires, , Argentina
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Mar Del Plata Buenos Aires, , Argentina
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Pilar Buenos Aires, , Argentina
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Quilmes Buenos Aires, , Argentina
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Lanus BuenosAires, , Argentina
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Rosario Santa Fe, , Argentina
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Cordoba , , Argentina
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Neuquen , , Argentina
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Santa Fe , , Argentina
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Edegem , , Belgium
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Gent , , Belgium
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Leuven , , Belgium
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Liege , , Belgium
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Fortaleza Ceara, , Brazil
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Belo Horizonte Mina Gerais, , Brazil
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Curitiba Parana, , Brazil
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Porto Alegre Rio Grande Do Sul, , Brazil
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Jau Sao Paulo, , Brazil
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Santo Andre Sao Paulo, , Brazil
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Sao Paulo - Sp Sao Paulo, , Brazil
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Sao Paulo , , Brazil
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Vancouver British Columbia, , Canada
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Oshawa Ontario, , Canada
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Toronto Ontario, , Canada
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Montreal Quebec, , Canada
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Beijing Beijing, , China
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Guangzhou Guangdong, , China
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Nanjing Jiangsu, , China
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Jinan Shandong, , China
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Beijing Shanghai, , China
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Xi'An Shanxi, , China
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Beijing , , China
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Shanghai , , China
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Angers , , France
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Avignon Cedex 2 , , France
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Bayonne , , France
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Besancon , , France
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Bobigny , , France
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Bordeaux , , France
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Clermont-Ferrand , , France
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Lyon , , France
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Nantes , , France
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Nice , , France
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Saint Brieuc Cedex , , France
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Saint-Cloud Cedex , , France
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St. Herblain Cedex , , France
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Strasbourg Cedex , , France
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Toulouse Cedex 3 , , France
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Berlin , , Germany
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Duisburg , , Germany
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Erlangen , , Germany
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Athens , , Greece
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Thessaloniki , , Greece
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Debrecen , , Hungary
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Gyor , , Hungary
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Pecs , , Hungary
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Brescia , , Italy
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Candiolo (To) , , Italy
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Forli , , Italy
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San Giovanni Rotondo , , Italy
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Incheon , , Korea, Republic of
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Seoul , , Korea, Republic of
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Nilai Negeri Sembilan, , Malaysia
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Kuala Lumpur , , Malaysia
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Acapulco Guerrero, , Mexico
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Merida Yucatan, , Mexico
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Chihuahua , , Mexico
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Distrito Federal , , Mexico
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San Luis Potosi , , Mexico
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Lima , , Peru
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Manila , , Philippines
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Quezon City , , Philippines
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Quezon , , Philippines
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Gdansk , , Poland
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Opole , , Poland
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Barcelona , , Spain
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Girona , , Spain
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Madrid , , Spain
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Valencia , , Spain
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Zaragoza , , Spain
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Gothenburg , , Sweden
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Stockholm , , Sweden
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Tainan , , Taiwan
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Taipei , , Taiwan
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Bangkok , , Thailand
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Bristol Avon, , United Kingdom
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Chelmsford Essex, , United Kingdom
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London Greater London, , United Kingdom
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Manchester Greater Manchester, , United Kingdom
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Sheffield South Yorkshire, , United Kingdom
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Guildford Surrey, , United Kingdom
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Newcastle-Upon-Tyne Tyne And Wear, , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

752

Study ID:

NCT00080301

Recruitment Status:

Completed

Sponsor:


R-Pharm

How clear is this clinincal trial information?

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