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Study Of Sunitinib With Capecitabine In Breast Cancer

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anjo-city, Aichi, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced/Metastatic Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not
amenable to surgery, radiation, or combined modality therapy with curative intent

- Measurable disease as per RECIST. Measurable lesions that have been previously
irradiated will not be considered target lesions unless increase in size has been
observed following completion of radiation therapy.

- Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or
metastatic disease settings.

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

- Histology of inflammatory carcinoma with no other measurable disease. Patients with
histology of inflammatory carcinoma are allowed on study if they have measurable
disease.

- Brain metastases, spinal cord compression, or carcinomatous meningitis, or
leptomeningeal disease.

- Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon
(5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1
(tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting

NCT00662025
Pfizer
Completed
Study Of Sunitinib With Capecitabine In Breast Cancer

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Study Of Sunitinib With Capecitabine In Breast Cancer
A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced/Metastatic Breast Cancer
  • Drug: Capecitabine
    Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
  • Drug: Sunitinib
    Sunitinib 37.5 mg daily, continuous dosing
Experimental: 1
Interventions:
  • Drug: Capecitabine
  • Drug: Sunitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
May 2012
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
  • Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
  • Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.

Exclusion Criteria:

  • Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
  • Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
  • Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
Sexes Eligible for Study: Female
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00662025
A6181163
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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