Clinical trial NCT00080301: Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Official title: A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Metastases
Keywords: Metastatic Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2004-03-30
Enrollment: 752
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
timeFrame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Secondary outcomes:
measure: Overall Response Rate (ORR) Per IRRC
timeFrame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
measure: Duration of Response Per IRRC
timeFrame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
measure: Time to Response Per IRRC
timeFrame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
measure: Overall Survival (OS)
timeFrame: from date of randomization until death
measure: Treatment-related Safety Summary
timeFrame: 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.
measure: Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
timeFrame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Vallejo
country: United States
facility: Local Institution
state: California
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Hartford
country: United States
facility: Local Institution
state: Connecticut
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: Burlington
country: United States
facility: Local Institution
state: Massachusetts
city: Jackson
country: United States
facility: Local Institution
state: Mississippi
city: Columbia
country: United States
facility: Local Institution
state: Missouri
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: Saint Louis
country: United States
facility: Local Institution
state: Missouri
city: Omaha
country: United States
facility: Local Institution
state: Nebraska
city: Livingston
country: United States
facility: Local Institution
state: New Jersey
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: Albuquerque
country: United States
facility: Local Institution
state: New Mexico
city: New York
country: United States
facility: Local Institution
state: New York
city: Columbus
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Tulsa
country: United States
facility: Local Institution
state: Oklahoma
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Greenville
country: United States
facility: Local Institution
state: South Carolina
city: Knoxville
country: United States
facility: Local Institution
state: Tennessee
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Ogden
country: United States
facility: Local Institution
state: Utah
city: Burlington
country: United States
facility: Local Institution
state: Vermont
city: Tacoma
country: United States
facility: Local Institution
state: Washington
city: Morgantown
country: United States
facility: Local Institution
state: West Virginia
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Haedo
country: Argentina
facility: Local Institution
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Pilar
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Lanus
country: Argentina
facility: Local Institution
state: BuenosAires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Cordoba
country: Argentina
facility: Local Institution
city: Neuquen
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Edegem
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Mina Gerais
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Jau
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo - Sp
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Oshawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Jinan
country: China
facility: Local Institution
state: Shandong
city: Beijing
country: China
facility: Local Institution
state: Shanghai
city: Xi'An
country: China
facility: Local Institution
state: Shanxi
city: Beijing
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
city: Angers
country: France
facility: Local Institution
city: Avignon Cedex 2
country: France
facility: Local Institution
city: Bayonne
country: France
facility: Local Institution
city: Besancon
country: France
facility: Local Institution
city: Bobigny
country: France
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Clermont-Ferrand
country: France
facility: Local Institution
city: Lyon
country: France
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
city: Nice
country: France
facility: Local Institution
city: Saint Brieuc Cedex
country: France
facility: Local Institution
city: Saint-Cloud Cedex
country: France
facility: Local Institution
city: St. Herblain Cedex
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Toulouse Cedex 3
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Duisburg
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Gyor
country: Hungary
facility: Local Institution
city: Pecs
country: Hungary
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Candiolo (To)
country: Italy
facility: Local Institution
city: Forli
country: Italy
facility: Local Institution
city: San Giovanni Rotondo
country: Italy
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Nilai
country: Malaysia
facility: Local Institution
state: Negeri Sembilan
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
city: Acapulco
country: Mexico
facility: Local Institution
state: Guerrero
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Chihuahua
country: Mexico
facility: Local Institution
city: Distrito Federal
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Manila
country: Philippines
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Quezon
country: Philippines
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Opole
country: Poland
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Girona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zaragoza
country: Spain
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Tainan
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Bristol
country: United Kingdom
facility: Local Institution
state: Avon
city: Chelmsford
country: United Kingdom
facility: Local Institution
state: Essex
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Sheffield
country: United Kingdom
facility: Local Institution
state: South Yorkshire
city: Guildford
country: United Kingdom
facility: Local Institution
state: Surrey
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.