Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

NCT00082433 | Completed Phase 3 Results DMC

• 1 other identifier: CA163-048
• Study Type: interventional
• Target: 1,221
• Locations: 28 countries
• Sites: 183

Brief Summary

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

Conditions

Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.

  from date of randomization until death

Secondary Outcomes (6)

• Progression-Free Survival (PFS)

  every 6 weeks (± 3 days) from randomization while on treatment until documented progression

• Response Rate (RR)

  every 6 weeks (± 3 days) from randomization while on treatment until documented progression

• Duration of Response

  every 6 weeks (± 3 days) from randomization while on treatment until documented progression

• Time to Response

  every 6 weeks (± 3 days) from randomization while on treatment until documented progression

• Treatment-Related Safety Summary

  safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.

Study Arms (2)

A

EXPERIMENTAL

Drug: Ixabepilone + Capecitabine

B

ACTIVE COMPARATOR

Drug: Capecitabine

Interventions

Ixabepilone + Capecitabine DRUG

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

Also known as: IXEMPRA®, Epothilone

A

Capecitabine DRUG

Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel). * 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (186)

Local Institution

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

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Related Publications (4)

• 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.

  PMID: 29522361 DERIVED

• 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.

  PMID: 24472478 DERIVED

• 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.

  PMID: 21937232 DERIVED

• 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.

  PMID: 21128114 DERIVED

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Interventions

ixabepilone; Capecitabine; Epothilones

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 7, 2004
• First Posted: May 11, 2004
• Study Start: November 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 2, 2020
• Results First Posted: August 17, 2009

Record last verified: 2020-10

Locations

KR (3); CZ (3); RU (3); CH (3); TU (3); AR (11); CA (2); NL (4); AU (11); SG (1); IT (12); DE (13); CR (2); BR (5); BE (6); FR (15); ES (15); GB (5); US (34); TW (1); CN (9); CL (1); DK (3); GR (4); IE (4); PT (2); IL (4); ZA (4)