Overview

This trial is active, not recruiting.

Condition advanced breast cancer
Treatments azd2171, fulvestrant
Phase phase 2
Target VEGF
Sponsor AstraZeneca
Start date March 2007
End date December 2008
Trial size 75 participants
Trial identifier NCT00454805, D8480C00007

Summary

The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Fulvestrant Monotherapy
fulvestrant Faslodex
intramuscular injection
(Experimental)
AZD2171 + Fulvestrant
azd2171 Recentin
Oral tablet
fulvestrant Faslodex
intramuscular injection

Primary Outcomes

Measure
Progression Free Survival
time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.

Secondary Outcomes

Measure
Objective Response Rate
time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Duration of Response
time frame: Every 8 weeks until progression or discontinuation
Clinical Benefit Rate
time frame: Every 8 weeks until progression or discontinuation
Duration of Clinical Benefit
time frame: Every 8 weeks until progression or discontinuation

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Written informed consent - Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease - One or more evaluable lesions Exclusion Criteria: - Prior hormonal therapy with fulvestrant - More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer - Prior biologic therapy for ABC including Anti-VEGF agents - Radiation therapy within 4 weeks prior to provision of consent

Additional Information

Official title A Phase II, Double-Blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of AZD2171 in Combination With Fulvestrant vs Fulvestrant Alone in Hormone Sensitive (ER+ve or PgR+ve) Post Menopausal Metastatic Breast Cancer Patients
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.