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-DE
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-05
• Last Update Posted: 4 February 2013

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy, in terms of PFS assessed by an independent radiology vendor, of bosutinib in combination with letrozole versus letrozole alone as first line treatment or as recurrence of adjuvant treatment for ER+/PgR+/erbB2- advanced or MBC in postmenopausal women.;Secondary Objective: · To evaluate the safety profile of bosutinib in combination with letrozole.<br>· To evaluate the PK of both bosutinib and letrozole in combination. <br>· To evaluate additional efficacy parameters such as ORR, overall survival (OS) at 3 years, duration of response, and PFS assessed by investigational sites.<br>· To examine the health-related quality of life (HRQoL) of bosutinib in combination with letrozole versus letrozole alone.<br>;Primary end point(s): Progression-Free Survival<br>PFS is the time interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last tumor evaluation.<br>