AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer

Advanced Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00454805
• Other study ID #: D8480C00007
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 29, 2007
• Last updated: January 11, 2016
• Start date: March 2007
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: National Health Surveillance AgencyAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2016
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• AZD2171
Oral tablet
• Fulvestrant
intramuscular injection

Locations

Country	Name	City	State
Australia	Research Site	Fitzroy
Australia	Research Site	Parkville
Australia	Research Site	Perth
Australia	Research Site	Waratah
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Curitiba
Brazil	Research Site	Fortaleza
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Santro Andre
Brazil	Research Site	São Paulo
United States	Research Site	Boca Raton	Florida
United States	Research Site	Burbank	California
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Los Angeles	California
United States	Research Site	New York	New York
United States	Research Site	Palm Springs	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.	RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.	No
Secondary	Objective Response Rate	Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as: Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.; Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase.; Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD	RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.	No
Secondary	Duration of Response	Number of days from date of response (complete/partial based on RECIST) to date of progression	Every 8 weeks until progression or discontinuation	No
Secondary	Clinical Benefit Rate	Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for =6 months.; The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off.	Every 8 weeks until progression or discontinuation	No
Secondary	Duration of Clinical Benefit	Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for =6 months.	Every 8 weeks until progression or discontinuation	No

External Links

•   CSR-D8480C00007.pdf