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-GB
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-18
• Last Update Posted: 19 March 2012

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