Clinical trial NCT00454805: AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Breast Cancer
Keywords: Advanced Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-04-02
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Secondary outcomes:
measure: Objective Response Rate
timeFrame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
measure: Duration of Response
timeFrame: Every 8 weeks until progression or discontinuation
measure: Clinical Benefit Rate
timeFrame: Every 8 weeks until progression or discontinuation
measure: Duration of Clinical Benefit
timeFrame: Every 8 weeks until progression or discontinuation
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: New York
country: United States
facility: Research Site
state: New York
city: Fitzroy
country: Australia
facility: Research Site
city: Parkville
country: Australia
facility: Research Site
city: Perth
country: Australia
facility: Research Site
city: Waratah
country: Australia
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Santro Andre
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Bijoyesh Mookerjee, MD
role: STUDY_DIRECTOR
References:
citation: Hyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P. Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs. 2013 Oct;31(5):1345-54. doi: 10.1007/s10637-013-9991-2. Epub 2013 Jun 26.