Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

NCT00393939

Last updated date
Study Location
Pfizer Investigational Site
Berkely, California, 94704, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
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

- Breast cancer with evidence of unresectable locally recurrent, or metastatic disease

- Her-2 negative tumors

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


- Patients for whom docetaxel is contraindicated


- Clinical presentation of inflammatory carcinoma with no other measurable disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
Official Title  ICMJE A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
Brief Summary This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Sunitinib malate
    Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
  • Drug: Taxotere
    Docetaxel 100 mg/m2 every 3 weeks in the comparator arm
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Sunitinib malate
  • Active Comparator: B
    Intervention: Drug: Taxotere
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: April 8, 2010)
594
Original Enrollment  ICMJE
 (submitted: October 30, 2006)
550
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
  • Her-2 negative tumors

Exclusion Criteria:

  • Patients for whom docetaxel is contraindicated
  • Clinical presentation of inflammatory carcinoma with no other measurable disease
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 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 Argentina,   Australia,   Austria,   Belgium,   Canada,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Netherlands,   Panama,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393939
Other Study ID Numbers  ICMJE A6181064
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 July 2012

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