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Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Bruxelles, , 1000 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
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.

- Tumors over-expressing Her-2

- Candidate for treatment with docetaxel/trastuzumab

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

- Histology of inflammatory carcinoma

- AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN

NCT00372424
Pfizer
Completed
Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

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Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
An Explorative Study Of The Tolerability Of SU011248 In Combination With Docetaxel And Trastuzumab As First-Line Treatment In Patients With Breast Cancer Over-Expressing HER-2
This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Herceptin
    Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.
    Other Name: trastuzumab
  • Drug: Sunitinib
    SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.
    Other Name: Sutent
  • Drug: Taxotere
    The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.
    Other Name: docetaxel
Experimental: 1
Combination of SU011248 (37.5 mg once daily [Schedule 2/1]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)
Interventions:
  • Drug: Herceptin
  • Drug: Sunitinib
  • Drug: Taxotere
Cardoso F, Canon JL, Amadori D, Aldrighetti D, Machiels JP, Bouko Y, Verkh L, Usari T, Kern KA, Giorgetti C, Dirix L. An exploratory study of sunitinib in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive metastatic breast cancer. Breast. 2012 Dec;21(6):716-23. doi: 10.1016/j.breast.2012.09.002. Epub 2012 Sep 27.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
  • Tumors over-expressing Her-2
  • Candidate for treatment with docetaxel/trastuzumab

Exclusion Criteria:

  • Histology of inflammatory carcinoma
  • AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy
 
 
NCT00372424
A6181113
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

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

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