Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: March 29, 2007
Last updated: July 6, 2016
Last verified: July 2016
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.

Condition Intervention Phase
Advanced Breast Cancer
Drug: AZD2171
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. ]
    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.

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. ]

    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

  • Duration of Response [ Time Frame: Every 8 weeks until progression or discontinuation ]
    Number of days from date of response (complete/partial based on RECIST) to date of progression

  • Clinical Benefit Rate [ Time Frame: Every 8 weeks until progression or discontinuation ]

    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.

  • Duration of Clinical Benefit [ Time Frame: Every 8 weeks until progression or discontinuation ]
    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.

Enrollment: 75
Study Start Date: March 2007
Study Completion Date: April 2016
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Fulvestrant Monotherapy
Drug: Fulvestrant
intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Experimental: 3
AZD2171 + Fulvestrant
Drug: AZD2171
Oral tablet
Other Name: Recentin
Drug: Fulvestrant
intramuscular injection
Other Names:
  • Faslodex
  • ZD9238


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00454805

United States, California
Research Site
Burbank, California, United States
Research Site
Los Angeles, California, United States
Research Site
Palm Springs, California, United States
United States, Florida
Research Site
Boca Raton, Florida, United States
United States, Hawaii
Research Site
Honolulu, Hawaii, United States
United States, New York
Research Site
New York, New York, United States
Research Site
Fitzroy, Australia
Research Site
Parkville, Australia
Research Site
Perth, Australia
Research Site
Waratah, Australia
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, Brazil
Sponsors and Collaborators
Study Director: Bijoyesh Mookerjee, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00454805     History of Changes
Other Study ID Numbers: D8480C00007
Study First Received: March 29, 2007
Results First Received: April 25, 2012
Last Updated: July 6, 2016

Keywords provided by AstraZeneca:
Advanced Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormones processed this record on May 25, 2017