Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer (SUN 1064) 


Tracking Information

Start Date  ICMJEFebruary 2007
Primary Completion DateSeptember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)		Progression free survival - Radiographic progression of disease [ Time Frame: From screening until disease progression ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: October 30, 2006)		Progression-free survival
Change HistoryComplete list of historical versions of study NCT00393939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 21, 2007)
  • Overall safety profile [ Time Frame: From screening until 28 days after last dose of study treatment ] [ Designated as safety issue: No ]
  • Patient reported outcomes [ Time Frame: From Cycle 1 Day 1 until end of treatment ] [ Designated as safety issue: No ]
  • Overall objective disease response [ Time Frame: From screening until progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From response until progressive disease ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From randomisation until death ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: October 30, 2006)		Overall survival Overall response rate Duration of response Patient reported outcome changes Overall safety profile.

Descriptive Information

Brief Title  ICMJEStudy Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
Official Title  ICMJEA 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 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEBreast 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 / Comparison Groups
  • A: Experimental
    Intervention: Drug: Sunitinib malate
  • B: Active Comparator
    Intervention: Drug: Taxotere

Recruitment Information

stimated Enrollment  ICMJE550
Estimated Completion DateJanuary 2012
Primary Completion DateSeptember 2009   (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
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer Oncology Clinical Trial Information Service1-877-369-9753PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   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

Administrative Information

NCT ID  ICMJENCT00393939
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study ID Numbers  ICMJEA6181064
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer