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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00454805
Recruitment Status : Completed
First Posted : April 2, 2007
Results First Posted : November 28, 2012
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: AZD2171 Drug: Fulvestrant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : March 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


  2. 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

  3. 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.


  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454805


Locations
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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
Australia
Research Site
Fitzroy, Australia
Research Site
Parkville, Australia
Research Site
Perth, Australia
Research Site
Waratah, Australia
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, Brazil
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Bijoyesh Mookerjee, MD AstraZeneca
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00454805    
Other Study ID Numbers: D8480C00007
First Posted: April 2, 2007    Key Record Dates
Results First Posted: November 28, 2012
Last Update Posted: August 3, 2016
Last Verified: July 2016
Keywords provided by AstraZeneca:
Advanced Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Cediranib
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action