A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Letrozole Versus Letrozole Alone as First Line Therapy in Post-Menopausal Women With Locally Advanced or Metastatic ER+/PgR+/erbB2- Breast Cancer

• Conditions: ocally advanced or metastatic ER+/PgR+/erbB2-breast cancer in post-menopausal women; MedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancer

• Registration Number: EUCTR2008-006252-21-HU
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

· Surgically sterile or postmenopausal women.

· Confirmed pathologic diagnosis of breast cancer.

· Locally advanced, metastatic, or locoregional recurrent breast cancer 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.

· At least 1 radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

· Eastern Cooperative Oncology Group (ECOG) performance status 0 to 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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior anti-Src therapy.

· Prior endocrine treatment for locally advanced or MBC.

· More than 1 prior cytotoxic chemotherapy regimen in metastatic setting. (Subjects may have received prior adjuvant or neoadjuvant chemotherapy.)

· Adjuvant AI therapy =12 months before day 1 of treatment.

· Adjuvant tamoxifen therapy =2 weeks before day 1 of treatment.

· Bone or skin as the only site of disease.

· Major surgery or radiotherapy within 14 days of treatment day 1.

· Extensive visceral disease or active central nervous system (CNS) disease.

· Any other cancer within 5 years of screening with the exception of ER+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.

· 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