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Completed

NCT Number: NCT00454805

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

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.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year–130 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Fitzroy, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2171

Drug

Oral tablet

Other names: Recentin

Fulvestrant

Drug

intramuscular injection

Other names: Faslodex, ZD9238

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2016
First posted
Apr 2, 2007
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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