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

NCT00080301 | Completed Phase 3 Results DMC

• 1 other identifier: CA163-046
• Study Type: interventional
• Target: 752
• Locations: 22 countries
• Sites: 127

Brief 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.

Conditions

Breast Cancer; Metastases

Keywords

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)

  PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.

  based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

Secondary Outcomes (6)

• Overall Response Rate (ORR) Per IRRC

  based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

• Duration of Response Per IRRC

  based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

• Time to Response Per IRRC

  based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

• Overall Survival (OS)

  from date of randomization until death

• 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 - 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

Also known as: BMS-247550, IXEMPRA, Epothilone

A

Capecitabine DRUG

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

B

Eligibility Criteria

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

* 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)

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 (127)

Local Institution

Little Rock, Arkansas, United States

Location

Local Institution

San Francisco, California, United States

Location

Local Institution

Vallejo, California, United States

Location

Local Institution

Denver, Colorado, United States

Location

Local Institution

Hartford, Connecticut, United States

Location

Local Institution

Washington D.C., District of Columbia, United States

Location

Local Institution

Orlando, Florida, United States

Location

Local Institution

Baltimore, Maryland, United States

Location

Local Institution

Burlington, Massachusetts, United States

Location

Local Institution

Jackson, Mississippi, United States

Location

Local Institution

Columbia, Missouri, United States

Location

Local Institution

Kansas City, Missouri, United States

Location

Local Institution

St Louis, Missouri, United States

Location

Local Institution

Omaha, Nebraska, United States

Location

Local Institution

Livingston, New Jersey, United States

Location

Local Institution

New Brunswick, New Jersey, United States

Location

Local Institution

Albuquerque, New Mexico, United States

Location

Local Institution

New York, New York, United States

Location

Local Institution

Columbus, Ohio, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

Tulsa, Oklahoma, United States

Location

Local Institution

Pittsburgh, Pennsylvania, United States

Location

Local Institution

Columbia, South Carolina, United States

Location

Local Institution

Greenville, South Carolina, United States

Location

Local Institution

Knoxville, Tennessee, United States

Location

Local Institution

Nashville, Tennessee, United States

Location

Local Institution

Austin, Texas, United States

Location

Local Institution

Houston, Texas, United States

Location

Local Institution

Ogden, Utah, United States

Location

Local Institution

Burlington, Vermont, United States

Location

Local Institution

Tacoma, Washington, United States

Location

Local Institution

Morgantown, West Virginia, United States

Location

Local Institution

Capital Federal, Buenos Aires, Argentina

Location

Local Institution

Haedo, Buenos Aires, Argentina

Location

Local Institution

La Plata, Buenos Aires, Argentina

Location

Local Institution

Mar del Plata, Buenos Aires, Argentina

Location

Local Institution

Pilar, Buenos Aires, Argentina

Location

Local Institution

Quilmes, Buenos Aires, Argentina

Location

Local Institution

Lanús, BuenosAires, Argentina

Location

Local Institution

Rosario, Santa Fe Province, Argentina

Location

Local Institution

Córdoba, Argentina

Location

Local Institution

Neuquén, Argentina

Location

Local Institution

Santa Fe, Argentina

Location

Local Institution

Edegem, Belgium

Location

Local Institution

Ghent, Belgium

Location

Local Institution

Leuven, Belgium

Location

Local Institution

Liège, Belgium

Location

Local Institution

Fortaleza, Ceará, Brazil

Location

Local Institution

Belo Horizonte, Mina Gerais, Brazil

Location

Local Institution

Curitiba, Paraná, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, Brazil

Location

Local Institution

Jaú, São Paulo, Brazil

Location

Local Institution

Santo André, São Paulo, Brazil

Location

Local Institution

Sao Paulo - Sp, São Paulo, Brazil

Location

Local Institution

São Paulo, Brazil

Location

Local Institution

Vancouver, British Columbia, Canada

Location

Local Institution

Oshawa, Ontario, Canada

Location

Local Institution

Toronto, Ontario, Canada

Location

Local Institution

Montreal, Quebec, Canada

Location

Local Institution

Beijing, Beijing Municipality, China

Location

Local Institution

Guangzhou, Guangdong, China

Location

Local Institution

Nanjing, Jiangsu, China

Location

Local Institution

Jinan, Shandong, China

Location

Local Institution

Beijing, Shanghai Municipality, China

Location

Local Institution

Xi’an, Shanxi, China

Location

Local Institution

Beijing, China

Location

Local Institution

Shanghai, China

Location

Local Institution

Angers, France

Location

Local Institution

Avignon, France

Location

Local Institution

Bayonne, France

Location

Local Institution

Besançon, France

Location

Local Institution

Bobigny, France

Location

Local Institution

Bordeaux, France

Location

Local Institution

Clermont-Ferrand, France

Location

Local Institution

Lyon, France

Location

Local Institution

Nantes, France

Location

Local Institution

Nice, France

Location

Local Institution

Saint-Brieuc, France

Location

Local Institution

Saint-Cloud, France

Location

Local Institution

Saint-Herblain, France

Location

Local Institution

Strasbourg, France

Location

Local Institution

Toulouse, France

Location

Local Institution

Berlin, Germany

Location

Local Institution

Duisburg, Germany

Location

Local Institution

Erlangen, Germany

Location

Local Institution

Athens, Greece

Location

Local Institution

Thessaloniki, Greece

Location

Local Institution

Budapest, Hungary

Location

Local Institution

Debrecen, Hungary

Location

Local Institution

Győr, Hungary

Location

Local Institution

Pécs, Hungary

Location

Local Institution

Brescia, Italy

Location

Local Institution

Candiolo (To), Italy

Location

Local Institution

Forlì, Italy

Location

Local Institution

San Giovanni Rotondo, Italy

Location

Local Institution

Kampung Baharu Nilai, Negeri Sembilan, Malaysia

Location

Local Institution

Kuala Lumpur, Malaysia

Location

Local Institution

Acapulco de Juárez, Guerrero, Mexico

Location

Local Institution

Mérida, Yucatán, Mexico

Location

Local Institution

Chihuahua City, Mexico

Location

Local Institution

Distrito Federal, Mexico

Location

Local Institution

San Luis Potosí City, Mexico

Location

Local Institution

Lima, Peru

Location

Local Institution

Manila, Philippines

Location

Local Institution

Quezon, Philippines

Location

Local Institution

Quezon City, Philippines

Location

Local Institution

Gdansk, Poland

Location

Local Institution

Opole, Poland

Location

Local Institution

Incheon, South Korea

Location

Local Institution

Seoul, South Korea

Location

Local Institution

Barcelona, Spain

Location

Local Institution

Girona, Spain

Location

Local Institution

Madrid, Spain

Location

Local Institution

Valencia, Spain

Location

Local Institution

Zaragoza, Spain

Location

Local Institution

Gothenburg, Sweden

Location

Local Institution

Stockholm, Sweden

Location

Local Institution

Tainan, Taiwan

Location

Local Institution

Taipei, Taiwan

Location

Local Institution

Bangkok, Thailand

Location

Local Institution

Bristol, Avon, United Kingdom

Location

Local Institution

Chelmsford, Essex, United Kingdom

Location

Local Institution

London, Greater London, United Kingdom

Location

Local Institution

Manchester, Greater Manchester, United Kingdom

Location

Local Institution

Sheffield, South Yorkshire, United Kingdom

Location

Local Institution

Guildford, Surrey, United Kingdom

Location

Local Institution

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 17968020 RESULT

• 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

Breast Neoplasms; Neoplasm Metastasis

Interventions

ixabepilone; Capecitabine; Epothilones

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: March 26, 2004
• First Posted: March 30, 2004
• Study Start: September 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: March 1, 2008
• Last Updated: November 2, 2020
• Results First Posted: August 17, 2009

Record last verified: 2020-10

Locations

US (32); PL (2); ME (5); CN (8); DE (3); PE (1); SE (2); GB (7); TW (2); BE (4); HU (4); TH (1); KR (2); BR (8); GR (2); MY (2); CA (4); IT (4); ES (5); PH (3); FR (15); AR (11)