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

NCT ID: NCT00080301

Last Updated: 2020-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Ixabepilone + Capecitabine

Intervention Type DRUG

Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity

Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

B

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Interventions

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Ixabepilone + Capecitabine

Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity

Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Intervention Type DRUG

Capecitabine

Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

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BMS-247550 IXEMPRA Epothilone

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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R-Pharm

INDUSTRY

Sponsor Role lead

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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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 D.C., 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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St 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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Lanús, BuenosAires, Argentina

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Rosario, Santa Fe Province, Argentina

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Córdoba, , Argentina

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Neuquén, , Argentina

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Santa Fe, , Argentina

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Edegem, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Fortaleza, Ceará, Brazil

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Belo Horizonte, Mina Gerais, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Jaú, São Paulo, Brazil

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Santo André, São Paulo, Brazil

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Sao Paulo - Sp, São Paulo, Brazil

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São 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 Municipality, 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 Municipality, 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, , France

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Bayonne, , France

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Besançon, , 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, , France

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Saint-Cloud, , France

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Saint-Herblain, , France

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Strasbourg, , France

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Toulouse, , 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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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Pécs, , Hungary

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Brescia, , Italy

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Candiolo (To), , Italy

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Forlì, , Italy

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San Giovanni Rotondo, , Italy

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Kampung Baharu Nilai, Negeri Sembilan, Malaysia

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Kuala Lumpur, , Malaysia

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Acapulco de Juárez, Guerrero, Mexico

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Mérida, Yucatán, Mexico

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Chihuahua City, , Mexico

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Distrito Federal, , Mexico

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San Luis Potosí City, , Mexico

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Lima, , Peru

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Manila, , Philippines

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Quezon, , Philippines

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Quezon City, , Philippines

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Gdansk, , Poland

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Opole, , Poland

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Incheon, , South Korea

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Seoul, , South Korea

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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 City, , 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

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Countries

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United States Argentina Belgium Brazil Canada China France Germany Greece Hungary Italy Malaysia Mexico Peru Philippines Poland South Korea Spain Sweden Taiwan Thailand United Kingdom

References

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Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roche HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. doi: 10.1200/JCO.2007.12.6557. Epub 2007 Oct 29.

Reference Type RESULT
PMID: 17968020 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24472478 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21937232 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21128114 (View on PubMed)

Other Identifiers

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CA163-046

Identifier Type: -

Identifier Source: org_study_id