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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Advanced Breast Cancer

Treatments

Drug: Fulvestrant

Drug: Dasatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00754325

CA180-158

USOR 06-030

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: