Study Of Sunitinib With Capecitabine In Breast Cancer

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NCT00662025

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Study Location
Pfizer Investigational Site
Anjo-city, Aichi, , Japan
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced/Metastatic Breast CancerStudy Of Sunitinib With Capecitabine In Breast Cancer
NCT00662025
  1. Anjo-city, Aichi
  2. Nagoya, Aichi
  3. Okazaki-City, Aichi
  4. Toyoake, Aichi
  5. Matsuyama-shi, Ehime
  6. Kure, Hiroshima
  7. Morioka, Iwate
  8. Yokohama, Kanagawa
  9. Sakai, Osaka
  10. Bunkyo-ku, Tokyo
  11. Koto-ku, Tokyo
  12. Chiba,
  13. Fukuoka,
  14. Kagoshima,
  15. Kyoto,
  16. Niigata,
  17. Osaka,
Female
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib With Capecitabine In Breast Cancer
Official Title  ICMJE A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer
Brief Summary To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced/Metastatic Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: Capecitabine
  • Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2010)		63
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)		62
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00662025
Other Study ID Numbers  ICMJE A6181163
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP