A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435409
• Other study ID #: A6181099
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2007
• Last updated: June 15, 2012
• Start date: February 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.

• Previous treatment with an anthracycline and a taxane in any setting

• Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months

Exclusion Criteria:

• History of inflammatory carcinoma if there is no other measurable disease

• More than 2 chemotherapy agents in the advanced disease setting

• Brain metastases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Sunitinib + Capecitabine
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day [1000 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.
• Capecitabine
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day [1250 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Linz
Austria	Pfizer Investigational Site	Salzburg
Austria	Pfizer Investigational Site	Wels
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Liege
Belgium	Pfizer Investigational Site	Namur
Belgium	Pfizer Investigational Site	Turnhout
Belgium	Pfizer Investigational Site	Yvoir
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Oshawa	Ontario
Czech Republic	Pfizer Investigational Site	Praha 4
Czech Republic	Pfizer Investigational Site	Praha 5
Czech Republic	Pfizer Investigational Site	Praha 5
Denmark	Pfizer Investigational Site	Aalborg
Denmark	Pfizer Investigational Site	Koebenhavn OE
Denmark	Pfizer Investigational Site	Odense
France	Pfizer Investigational Site	Angers cedex 01
France	Pfizer Investigational Site	BORDEAUX Cedex
France	Pfizer Investigational Site	CAEN Cedex 5
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Montpellier	Cedex 05
France	Pfizer Investigational Site	Nancy
France	Pfizer Investigational Site	Paris
Germany	Pfizer Investigational Site	Erlangen
Germany	Pfizer Investigational Site	Frankenthal
Germany	Pfizer Investigational Site	Frankfurt am Main
Germany	Pfizer Investigational Site	Fuerstenwalde
Germany	Pfizer Investigational Site	Goettingen
Germany	Pfizer Investigational Site	Muenster
Germany	Pfizer Investigational Site	Nuernberg
Germany	Pfizer Investigational Site	Stendal
Germany	Pfizer Investigational Site	Ulm
Germany	Pfizer Investigational Site	Voelklingen
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Heraklion	Crete
Greece	Pfizer Investigational Site	Ioannina
Greece	Pfizer Investigational Site	Patras
Greece	Pfizer Investigational Site	Thessaloniki
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Dublin
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Brescia
Italy	Pfizer Investigational Site	Messina
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Palermo
Italy	Pfizer Investigational Site	Parma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Saronno (VA)
Italy	Pfizer Investigational Site	Torino
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Sittard-geleen
Netherlands	Pfizer Investigational Site	Zwolle
Norway	Pfizer Investigational Site	Levanger
Norway	Pfizer Investigational Site	Oslo
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Romania	Pfizer Investigational Site	Bucuresti	Sector 2
Romania	Pfizer Investigational Site	Cluj-Napoca	Cluj
Russian Federation	Pfizer Investigational Site	Kuzmolovo, Vsevolozhsk district	Leningrad region
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Burgos
Spain	Pfizer Investigational Site	Cadiz
Spain	Pfizer Investigational Site	La Coruña
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Sevilla
United Kingdom	Pfizer Investigational Site	Birmingham
United Kingdom	Pfizer Investigational Site	Burton upon Trent	Staffordshire
United Kingdom	Pfizer Investigational Site	Chelmsford	Essex
United Kingdom	Pfizer Investigational Site	Essex
United Kingdom	Pfizer Investigational Site	Harlow	Essex
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Swansea
United Kingdom	Pfizer Investigational Site	Truro
United Kingdom	Pfizer Investigational Site	Truro	Cornwall
United Kingdom	Pfizer Investigational Site	Worthing
United Kingdom	Pfizer Investigational Site	Worthing	West Sussex
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Avon	Indiana
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Billings	Montana
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Bountiful	Utah
United States	Pfizer Investigational Site	Boynton Beach	Florida
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Clairton	Pennsylvania
United States	Pfizer Investigational Site	Columbia	Missouri
United States	Pfizer Investigational Site	Coral Springs	Florida
United States	Pfizer Investigational Site	Corinth	Mississippi
United States	Pfizer Investigational Site	Corpus Christi	Texas
United States	Pfizer Investigational Site	Corpus Christi	Texas
United States	Pfizer Investigational Site	Covington	Louisiana
United States	Pfizer Investigational Site	Downey	California
United States	Pfizer Investigational Site	Duluth	Georgia
United States	Pfizer Investigational Site	Franklin	Tennessee
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Gallatin	Tennessee
United States	Pfizer Investigational Site	Georgetown	Texas
United States	Pfizer Investigational Site	Greensburg	Pennsylvania
United States	Pfizer Investigational Site	Gretna	Louisiana
United States	Pfizer Investigational Site	Hermitage	Tennessee
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Kennewick	Washington
United States	Pfizer Investigational Site	Kensington	Maryland
United States	Pfizer Investigational Site	Lake Worth	Florida
United States	Pfizer Investigational Site	Lakeland	Florida
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Layton	Utah
United States	Pfizer Investigational Site	Lebanon	Tennessee
United States	Pfizer Investigational Site	Marrero	Louisiana
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Montebello	California
United States	Pfizer Investigational Site	Mooresville	Indiana
United States	Pfizer Investigational Site	Murfreesboro	Tennessee
United States	Pfizer Investigational Site	Murray	Utah
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Norman	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pottstown	Pennsylvania
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Smyrna	Tennessee
United States	Pfizer Investigational Site	Snellville	Georgia
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	West Provo	Utah
United States	Pfizer Investigational Site	West Valley City	Utah
United States	Pfizer Investigational Site	Wexford	Pennsylvania
United States	Pfizer Investigational Site	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Norway,  Poland,  Romania,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.	Baseline until disease progression (up to 3 years from first dose)	No
Secondary	Percentage of Participants With Objective Response (OR)	Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.	Baseline until response or disease progression (up to 3 years from first dose)	No
Secondary	Duration of Response (DR)	Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.	Baseline until response or disease progression (up to 3 years from first dose)	No
Secondary	Overall Survival (OS)	Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.	Baseline until death or up to 3 years from first dose	No
Secondary	Percent Chance of Participant Survival	Probability of survival 2 years and 3 years after the first dose of study treatment.	Year 1, Year 2, Year 3	No
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30)	EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms	Day 1 of each treatment cycle (up to 3 years or end of treatment)	No
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)	BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.	Day 1 of each treatment cycle (up to 3 years or end of treatment)	No
Secondary	Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)	EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.	Day 1 of each treatment cycle (up to 3 years or end of treatment)	No

External Links

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