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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Advanced Breast Cancer

Treatments: Drug: exemestane; Drug: Exemestane; Drug: Bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793546

B1871009

3160A6-2206

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

1

Experimental group

Description:

combination of bosutinib and exemestane

Treatment:

Drug: Bosutinib

Drug: exemestane

2

Active Comparator group

Description:

exemestane

Treatment:

Drug: Exemestane