Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer

NCT ID: NCT00291577

Last Updated: 2009-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-02-28

Brief Summary

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This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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advanced sunitinib (Sutent) docetaxel Phase 1B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Sunitinib (Sutent)

Intervention Type DRUG

Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision

Taxotere

Intervention Type DRUG

Taxotere 75 mg/m2 iv, once every 3 weeks

Interventions

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Sunitinib (Sutent)

Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision

Intervention Type DRUG

Taxotere

Taxotere 75 mg/m2 iv, once every 3 weeks

Intervention Type DRUG

Other Intervention Names

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Sutent

Eligibility Criteria

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Inclusion Criteria

* Breast cancer with evidence of unresectable, locally recurrent or metastatic disease
* Candidate for treatment with docetaxel

Exclusion Criteria

* Prior chemotherapy in the advanced disease setting
* Inflammatory breast cancer
* HER2 positive disease
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Countries

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Belgium Italy Sweden

Related Links

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Other Identifiers

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A6181100

Identifier Type: -

Identifier Source: org_study_id