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Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

NCT ID: NCT00793546

Last Updated: 2012-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-06-30

Brief Summary

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This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.

Detailed Description

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This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. Even if the safety profile of the combination of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver events including 14% of severe liver events.

Conditions

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Advanced Breast Cancer

Keywords

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Bosutinib Exemestane postmenopausal breast cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

combination of bosutinib and exemestane

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

exemestane

Intervention Type DRUG

25 mg tablet once daily

2

exemestane

Group Type ACTIVE_COMPARATOR

Exemestane

Intervention Type DRUG

25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

Interventions

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Bosutinib

300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

Intervention Type DRUG

exemestane

25 mg tablet once daily

Intervention Type DRUG

Exemestane

25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Woman aged 18 years or older.
* Confirmed pathologic diagnosis of breast cancer.
* Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
* Surgically sterile or postmenopausal woman.
* Documented ER+ and/or PgR+ and erbB2- tumor.
* Progression of locally advanced or metastatic disease during treatment with a nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant nonsteroidal AI.

Exclusion Criteria

* Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
* More than 1 prior endocrine treatment for locally advanced or MBC.
* More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
* Bone or skin as the only site of 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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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Lake Worth, Florida, United States

Site Status

Pfizer Investigational Site

Joliet, Illinois, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Detroit, Michigan, United States

Site Status

Pfizer Investigational Site

New Brunswick, New Jersey, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Bethlehem, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

South Brisbane, Queensland, Australia

Site Status

Pfizer Investigational Site

Brussels, Brussels Capital, Belgium

Site Status

Pfizer Investigational Site

Leuven, Leuven, Belgium

Site Status

Pfizer Investigational Site

Liège, Liege, Belgium

Site Status

Pfizer Investigational Site

Wilrijk, , Belgium

Site Status

Pfizer Investigational Site

Kelowna, British Columbia, Canada

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Hong Kong, , Hong Kong

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Mumbai, Maharashtra, India

Site Status

Pfizer Investigational Site

Pune, Maharashtra, India

Site Status

Pfizer Investigational Site

Olsztyn, , Poland

Site Status

Pfizer Investigational Site

Lynnwood, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Valencia, Valencia, Spain

Site Status

Pfizer Investigational Site

, ,

Site Status

Countries

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Argentina Brazil France Netherlands Serbia Singapore South Korea United Kingdom United States Australia Belgium Canada China Hong Kong Hungary India Poland South Africa Spain

References

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Moy B, Neven P, Lebrun F, Bellet M, Xu B, Sarosiek T, Chow L, Goss P, Zacharchuk C, Leip E, Turnbull K, Bardy-Bouxin N, Duvillie L, Lang I. Bosutinib in combination with the aromatase inhibitor exemestane: a phase II trial in postmenopausal women with previously treated locally advanced or metastatic hormone receptor-positive/HER2-negative breast cancer. Oncologist. 2014 Apr;19(4):346-7. doi: 10.1634/theoncologist.2014-0022. Epub 2014 Mar 27.

Reference Type DERIVED
PMID: 24674873 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3160A6-2206&StudyName=Study%20Evaluating%20Bosutinib-Exemestane%20Combination%20Vs%20Exemestane%20Alone%20in%20Post%20Menopausal%20Women%20With%20Breast%20Cancer

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Other Identifiers

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B1871009

Identifier Type: -

Identifier Source: secondary_id

3160A6-2206

Identifier Type: -

Identifier Source: org_study_id