Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Aromatase Inhibitors; Dasatinib; Estradiol; Fulvestrant; Hormones

Criteria

For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+) and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry (IHC)

• Measureable or evaluable-only disease

• human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer

• Males and females ≥18 years of age

• Females are post menopausal or surgically sterile

• Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)

Exclusion Criteria:

• Pregnant or breast feeding

• >1 chemotherapy regimen for advanced disease

• Pleural or pericardial effusion

• Serious cardiac condition