Clinical trial NCT00082433: Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Official title: A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2004-05-11
Enrollment: 1221
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 (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.


Eligibility criteria: * 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)

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: from date of randomization until death
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
measure: Response Rate (RR)
timeFrame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
measure: Duration of Response
timeFrame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
measure: Time to Response
timeFrame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
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: Tucson
country: United States
facility: Local Institution
state: Arizona
city: Beverly Hills
country: United States
facility: Local Institution
state: California
city: Corona
country: United States
facility: Local Institution
state: California
city: Hartford
country: United States
facility: Local Institution
state: Connecticut
city: Plantation
country: United States
facility: Local Institution
state: Florida
city: Boise
country: United States
facility: Local Institution
state: Idaho
city: Evanston
country: United States
facility: Local Institution
state: Illinois
city: Iowa City
country: United States
facility: Local Institution
state: Iowa
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Baton Rouge
country: United States
facility: Local Institution
state: Louisiana
city: Bethesda
country: United States
facility: Local Institution
state: Maryland
city: Boston
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: Voorhees
country: United States
facility: Local Institution
state: New Jersey
city: Albuquerque
country: United States
facility: Local Institution
state: New Mexico
city: Bronx
country: United States
facility: Local Institution
state: New York
city: Latham
country: United States
facility: Local Institution
state: New York
city: Mineola
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Goldsboro
country: United States
facility: Local Institution
state: North Carolina
city: Hickory
country: United States
facility: Local Institution
state: North Carolina
city: Kinston
country: United States
facility: Local Institution
state: North Carolina
city: Canton
country: United States
facility: Local Institution
state: Ohio
city: Columbus
country: United States
facility: Local Institution
state: Ohio
city: Langhorne
country: United States
facility: Local Institution
state: Pennsylvania
city: Knoxville
country: United States
facility: Local Institution
state: Tennessee
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Charlottesville
country: United States
facility: Local Institution
state: Virginia
city: Norfolk
country: United States
facility: Local Institution
state: Virginia
city: Richmond
country: United States
facility: Local Institution
state: Virginia
city: Marshfield
country: United States
facility: Local Institution
state: Wisconsin
city: Avelianeda
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Bahia Blanca
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Escobar
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Resistencia
country: Argentina
facility: Local Institution
state: Chaco
city: Barrio Alto Verde
country: Argentina
facility: Local Institution
state: Cordoba
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Mendoza
country: Argentina
facility: Local Institution
city: Salta
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Sydney
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: South Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Toowoomba
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: East Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Perth
country: Australia
facility: Local Institution
state: Western Australia
city: Graz
country: Austria
facility: Local Institution
city: Voecklabruck
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Charleroi
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Hasselt
country: Belgium
facility: Local Institution
city: Kortrijk
country: Belgium
facility: Local Institution
city: Wilrijk
country: Belgium
facility: Local Institution
city: Centro-Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Bela Vista
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Higienopolis
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
state: Sp
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Thunder Bay
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
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: Dalian
country: China
facility: Local Institution
state: Liaoning
city: Dilian
country: China
facility: Local Institution
state: Liaoning
city: Jinan
country: China
facility: Local Institution
state: Shandong
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Xi'An
country: China
facility: Local Institution
state: Shanxi
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Split
country: Croatia
facility: Local Institution
city: Zagreb
country: Croatia
facility: Local Institution
city: Brno
country: Czechia
facility: Local Institution
city: Hradec Kralove
country: Czechia
facility: Local Institution
city: Prague 5
country: Czechia
facility: Local Institution
city: Prague
country: Czechia
facility: Local Institution
city: Aalborg
country: Denmark
facility: Local Institution
city: Herlev
country: Denmark
facility: Local Institution
city: Kobenhavn O
country: Denmark
facility: Local Institution
city: Angers
country: France
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Caen
country: France
facility: Local Institution
city: Clermont-Ferrand
country: France
facility: Local Institution
city: Colmar
country: France
facility: Local Institution
city: Le Mans
country: France
facility: Local Institution
city: Metz
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Pierre Benite
country: France
facility: Local Institution
city: Reims
country: France
facility: Local Institution
city: Saint Brieuc
country: France
facility: Local Institution
city: Saint Gregoire
country: France
facility: Local Institution
city: Saint Herblain
country: France
facility: Local Institution
city: Tours Cedex
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Karlsruhe
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Marburg
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Rehling
country: Germany
facility: Local Institution
city: Saarbrucken
country: Germany
facility: Local Institution
city: Tubingen
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Wiesbaden
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Crete
country: Greece
facility: Local Institution
city: Patras
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Wilton
country: Ireland
facility: Local Institution
state: Cork
city: Cork
country: Ireland
facility: Local Institution
city: Dublin 8
country: Ireland
facility: Local Institution
city: Dublin 9
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Galway
country: Ireland
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Ramat-Gan
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Rozzano
country: Italy
facility: Local Institution
state: Milan
city: Bari
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Perugia
country: Italy
facility: Local Institution
city: Potenza
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: San Giovanni Rotondo
country: Italy
facility: Local Institution
city: Sora
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Gyeonggi-Do
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Arnhem
country: Netherlands
facility: Local Institution
city: Den Haag
country: Netherlands
facility: Local Institution
city: Enschede
country: Netherlands
facility: Local Institution
city: Zwolle
country: Netherlands
facility: Local Institution
city: Coimbra
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Kazan
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Panorama
country: South Africa
facility: Local Institution
state: Western Cape
city: Terassa
country: Spain
facility: Local Institution
state: Barcelona
city: Barcelona
country: Spain
facility: Local Institution
city: Cadiz
country: Spain
facility: Local Institution
city: Cordoba
country: Spain
facility: Local Institution
city: Elche (Alicante)
country: Spain
facility: Local Institution
city: Hospitalet De Llobregat
country: Spain
facility: Local Institution
city: Jaen
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Pontevedra
country: Spain
facility: Local Institution
city: Reus
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Tenerife
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zaragoza
country: Spain
facility: Local Institution
city: Bern
country: Switzerland
facility: Local Institution
city: Thun
country: Switzerland
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Ankara
country: Turkey
facility: Local Institution
city: Istanbul
country: Turkey
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
city: Belfast
country: United Kingdom
facility: Local Institution
state: Armagh
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Central
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Shrewsbury
country: United Kingdom
facility: Local Institution
state: Shropshire
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
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.