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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

NCT00754325 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-05-26

Study results available
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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.

Conditions

Interventions

DRUG

Fulvestrant

Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years

DRUG

Dasatinib

Tablets, Oral, 100 mg, once daily (QD), upto 2 years

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-11-30
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00754325 on ClinicalTrials.gov