A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Exemestane vs. Exemestane Alone as Second Line Therapy in Post-Menopausal Women with Locally Advanced or Metastatic ER+/PgR+/Her2- Breast Cancer

• Conditions: ocally advanced or metastatic ER+/PgR+/Her2-breast cancer in post-menopausal women; MedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancer

• Registration Number: EUCTR2008-002457-20-BE
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-21
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 194

Inclusion Criteria

• Post-menopausal women.
• Confirmed pathologic diagnosis of breast cancer.
• Locally advanced or metastatic, or loco-regional recurrent and not amenable to curative treatment with surgery or radiotherapy.
• Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.
• Progression of locally advanced or metastatic disease during treatment with a non-steroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant non-steroidal AI.
• At least 1 radiologically measurable lesion as defined by RECIST
• ECOG performance status 0-2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prior exemestane, prior bosutinib, or any other prior Src inhibitor.
• More than 1 prior endocrine treatment for locally advanced or metastatic breast cancer.
• More than 1 prior chemotherapy regimen in metastatic setting
• Subjects with bone or skin as the only site of disease
• Extensive visceral disease or active CNS disease.
• Any other cancer within 5 years of screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
• Major surgery or radiotherapy within 14 days of treatment day 1.
• No adequate hepatic/renal/bone marrow function.
• History of clinically significant or uncontrolled cardiac disease
• Serious concurrent illness.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare efficacy, as measured by PFS and assessed by an independent radiology read, of bosutinib in combination with exemestane with that of exemestane alone.;Secondary Objective: The secondary objectives are to evaluate the safety profile of bosutinib in combination with exemestane, to evaluate the population pharmacokinetics (PK) of bosutinib in combination with exemestane, and to evaluate additional efficacy parameters: PFS per sites assessment, overall response rate, 2-year overall survival, and duration of response.<br><br>An exploratory objective is to analyze biomarkers for prediction of response to treatment with bosutinib in combination with exemestane;Primary end point(s): To compare the efficacy, in terms of progression free survival (PFS) assessed by an independent radiology vendor, of bosutinib in combination with exemestane versus exemestane alone as second line treatment for ER+/PgR+/HER2- advanced or metastatic breast cancer in postmenopausal women