AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00454805
First received: March 29, 2007
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: June 2014
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454805

Locations
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
Research Site
Miami, 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, New South Wales
Research Site
Waratah, New South Wales, Australia
Australia, Victoria
Research Site
Fitzroy, Victoria, Australia
Research Site
Parkville, Victoria, Australia
Australia, Western Australia
Research Site
Perth, Western Australia, Australia
Australia
Research Site
Fitzroy, Australia
Research Site
Parkville, Australia
Research Site
Perth, Australia
Research Site
Waratah, Australia
Brazil
Research Site
Fortaleza, CE, Brazil
Research Site
Belo Horizonte, MG, Brazil
Research Site
Curitiba, PR, Brazil
Research Site
Porto Alegre, RS, Brazil
Research Site
Santro Andre, SP, Brazil
Research Site
Sao Paulo, SP, 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
Study Director: Bijoyesh Mookerjee, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00454805     History of Changes
Other Study ID Numbers: D8480C00007
Study First Received: March 29, 2007
Results First Received: April 25, 2012
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:
Advanced Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on April 16, 2014