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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080301
• Other study ID #: CA163-046
• Status: Completed
• Phase: Phase 3
• Start date: September 2003
• Est. completion date: March 2008

Study information

• Verified date: October 2020
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: March 2008
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastases

Intervention

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

Locations

Country	Name	City	State
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Haedo	Buenos Aires
Argentina	Local Institution	La Plata	Buenos Aires
Argentina	Local Institution	Lanus	BuenosAires
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Argentina	Local Institution	Neuquen
Argentina	Local Institution	Pilar	Buenos Aires
Argentina	Local Institution	Quilmes	Buenos Aires
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	Santa Fe
Belgium	Local Institution	Edegem
Belgium	Local Institution	Gent
Belgium	Local Institution	Leuven
Belgium	Local Institution	Liege
Brazil	Local Institution	Belo Horizonte	Mina Gerais
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Fortaleza	Ceara
Brazil	Local Institution	Jau	Sao Paulo
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Santo Andre	Sao Paulo
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo - Sp	Sao Paulo
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Oshawa	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Shanghai
China	Local Institution	Beijing
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Jinan	Shandong
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Shanghai
China	Local Institution	Xi'An	Shanxi
France	Local Institution	Angers
France	Local Institution	Avignon Cedex 2
France	Local Institution	Bayonne
France	Local Institution	Besancon
France	Local Institution	Bobigny
France	Local Institution	Bordeaux
France	Local Institution	Clermont-Ferrand
France	Local Institution	Lyon
France	Local Institution	Nantes
France	Local Institution	Nice
France	Local Institution	Saint Brieuc Cedex
France	Local Institution	Saint-Cloud Cedex
France	Local Institution	St. Herblain Cedex
France	Local Institution	Strasbourg Cedex
France	Local Institution	Toulouse Cedex 3
Germany	Local Institution	Berlin
Germany	Local Institution	Duisburg
Germany	Local Institution	Erlangen
Greece	Local Institution	Athens
Greece	Local Institution	Thessaloniki
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Hungary	Local Institution	Gyor
Hungary	Local Institution	Pecs
Italy	Local Institution	Brescia
Italy	Local Institution	Candiolo (To)
Italy	Local Institution	Forli
Italy	Local Institution	San Giovanni Rotondo
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seoul
Malaysia	Local Institution	Kuala Lumpur
Malaysia	Local Institution	Nilai	Negeri Sembilan
Mexico	Local Institution	Acapulco	Guerrero
Mexico	Local Institution	Chihuahua
Mexico	Local Institution	Distrito Federal
Mexico	Local Institution	Merida	Yucatan
Mexico	Local Institution	San Luis Potosi
Peru	Local Institution	Lima
Philippines	Local Institution	Manila
Philippines	Local Institution	Quezon
Philippines	Local Institution	Quezon City
Poland	Local Institution	Gdansk
Poland	Local Institution	Opole
Spain	Local Institution	Barcelona
Spain	Local Institution	Girona
Spain	Local Institution	Madrid
Spain	Local Institution	Valencia
Spain	Local Institution	Zaragoza
Sweden	Local Institution	Gothenburg
Sweden	Local Institution	Stockholm
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Taipei
Thailand	Local Institution	Bangkok
United Kingdom	Local Institution	Bristol	Avon
United Kingdom	Local Institution	Chelmsford	Essex
United Kingdom	Local Institution	Guildford	Surrey
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United Kingdom	Local Institution	Newcastle-Upon-Tyne	Tyne And Wear
United Kingdom	Local Institution	Sheffield	South Yorkshire
United States	Local Institution	Albuquerque	New Mexico
United States	Local Institution	Austin	Texas
United States	Local Institution	Baltimore	Maryland
United States	Local Institution	Burlington	Massachusetts
United States	Local Institution	Burlington	Vermont
United States	Local Institution	Columbia	South Carolina
United States	Local Institution	Columbia	Missouri
United States	Local Institution	Columbus	Ohio
United States	Local Institution	Denver	Colorado
United States	Local Institution	Greenville	South Carolina
United States	Local Institution	Hartford	Connecticut
United States	Local Institution	Houston	Texas
United States	Local Institution	Jackson	Mississippi
United States	Local Institution	Kansas City	Missouri
United States	Local Institution	Knoxville	Tennessee
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Livingston	New Jersey
United States	Local Institution	Morgantown	West Virginia
United States	Local Institution	Nashville	Tennessee
United States	Local Institution	New Brunswick	New Jersey
United States	Local Institution	New York	New York
United States	Local Institution	Ogden	Utah
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	Omaha	Nebraska
United States	Local Institution	Orlando	Florida
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution	Saint Louis	Missouri
United States	Local Institution	San Francisco	California
United States	Local Institution	Tacoma	Washington
United States	Local Institution	Tulsa	Oklahoma
United States	Local Institution	Vallejo	California
United States	Local Institution	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Countries where clinical trial is conducted

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

References & Publications (1)

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, Roché HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Response Rate (ORR) Per IRRC	Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Secondary	Duration of Response Per IRRC	Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Secondary	Time to Response Per IRRC	Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Secondary	Overall Survival (OS)	OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.	from date of randomization until death
Secondary	Treatment-related Safety Summary	Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0	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.
Secondary	Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)	Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.	Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.