Overview

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