Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
NCT ID: NCT00082433
Last Updated: 2020-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1221 participants
INTERVENTIONAL
2003-11-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Ixabepilone + Capecitabine
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
B
Capecitabine
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle
Interventions
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Ixabepilone + Capecitabine
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
Capecitabine
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.
* Patients may not have any history of brain and/or leptomeningeal metastases.
* Patients may not have Grade 2 or worse neuropathy at the time of study entry.
* Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)
18 Years
FEMALE
No
Sponsors
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R-Pharm
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Corona, California, United States
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Hartford, Connecticut, United States
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Plantation, Florida, United States
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Boise, Idaho, United States
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Evanston, Illinois, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Jackson, Mississippi, United States
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Columbia, Missouri, United States
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Voorhees Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Latham, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Goldsboro, North Carolina, United States
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Hickory, North Carolina, United States
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Kinston, North Carolina, United States
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Langhorne, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Marshfield, Wisconsin, United States
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Avellaneda, Buenos Aires, Argentina
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Bahía Blanca, Buenos Aires, Argentina
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Belén de Escobar, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Resistencia, Chaco Province, Argentina
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Barrio Alto Verde, Córdoba Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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Mendoza, , Argentina
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Salta, , Argentina
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Santa Fe, , Argentina
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Sydney, New South Wales, Australia
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Westmead, New South Wales, Australia
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Brisbane, Queensland, Australia
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Herston, Queensland, Australia
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South Brisbane, Queensland, Australia
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Toowoomba, Queensland, Australia
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Adelaide, South Australia, Australia
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Woodville, South Australia, Australia
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East Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Perth, Western Australia, Australia
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Graz, , Austria
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Vienna, , Austria
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Vöcklabruck, , Austria
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Brussels, , Belgium
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Charleroi, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Kortrijk, , Belgium
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Wilrijk, , Belgium
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Centro-Porto Alegre, Rio Grande do Sul, Brazil
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Bela Vista, São Paulo, Brazil
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Higienopolis, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Thunder Bay, Ontario, Canada
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Montreal, Quebec, Canada
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Santiago, Santiago Metropolitan, Chile
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Nanjing, Jiangsu, China
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Dalian, Liaoning, China
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Dilian, Liaoning, China
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Jinan, Shandong, China
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Shanghai, Shanghai Municipality, China
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Xi’an, Shanxi, China
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Hangzhou, Zhejiang, China
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Split, , Croatia
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Zagreb, , Croatia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Herlev, , Denmark
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København Ø, , Denmark
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Angers, , France
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Bordeaux, , France
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Caen, , France
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Clermont-Ferrand, , France
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Colmar, , France
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Le Mans, , France
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Metz, , France
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Paris, , France
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Pierre-Bénite, , France
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Reims, , France
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Saint-Brieuc, , France
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Saint-Grégoire, , France
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Saint-Herblain, , France
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Tours, , France
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Villejuif, , France
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Berlin, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Hanover, , Germany
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Karlsruhe, , Germany
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Kiel, , Germany
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Marburg, , Germany
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München, , Germany
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Rehling, , Germany
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Saarbrücken, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Athens, , Greece
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Crete, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Wilton, Cork, Ireland
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Cork, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Haifa, , Israel
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Jerusalem, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Rozzano, Milan, Italy
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Bari, , Italy
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Modena, , Italy
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Perugia, , Italy
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Potenza, , Italy
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Roma, , Italy
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San Giovanni Rotondo, , Italy
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Sora, , Italy
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Torino, , Italy
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Arnhem, , Netherlands
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Enschede, , Netherlands
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The Hague, , Netherlands
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Zwolle, , Netherlands
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Coimbra, , Portugal
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Lisbon, , Portugal
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Kazan', , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Port Elizabeth, Eastern Cape, South Africa
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Panorama, Western Cape, South Africa
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Gyeonggi-do, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Terassa, Barcelona, Spain
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Barcelona, , Spain
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Cadiz, , Spain
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Córdoba, , Spain
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Elche (Alicante), , Spain
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Jaén, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Pontevedra, , Spain
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Reus, , Spain
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Salamanca, , Spain
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Santa Cruz de Tenerife, , Spain
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Seville, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Bern, , Switzerland
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Thun, , Switzerland
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Zurich, , Switzerland
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Belfast, Armagh, United Kingdom
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Glasgow, Central, United Kingdom
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London, Greater London, United Kingdom
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Shrewsbury, Shropshire, United Kingdom
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Birmingham, West Midlands, United Kingdom
Countries
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References
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Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.
Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.
Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.
Other Identifiers
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CA163-048
Identifier Type: -
Identifier Source: org_study_id