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

Last updated on November 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Downey, California, 90241 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

- More than 2 chemotherapy agents in the advanced disease setting

- Brain metastases

NCT00435409
Pfizer
Completed
A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

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A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer
The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • 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.

  • Drug: 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.
  • Experimental: A
    Intervention: Drug: Sunitinib + Capecitabine
  • Active Comparator: B
    Intervention: Drug: Capecitabine
Crown JP, Diéras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
442
June 2011
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Ireland,   Italy,   Netherlands,   Norway,   Poland,   Romania,   Russian Federation,   Spain,   United Kingdom,   United States
Puerto Rico
 
NCT00435409
A6181099
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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