IRESSA™ (Gefitinib) in Breast Cancer Patients

April 21, 2009 updated by: AstraZeneca

A Phase II Trial to Assess the Efficacy of IRESSA™ (Gefitinib) 500 mg/Day in Patients With Breast Cancer Who Have Failed Tamoxifen or Have an Oestrogen Receptor Negative Tumour and Would be Considered for Systemic Therapy

This is a phase II trial to assess whether IRESSA™ (gefitinib) has anti-tumour efficacy in patients with breast cancer. The trial proposes to enter 27 patients who have acquired resistance to tamoxifen and 27 patients with ER negative tumours. However for each of these two types of patients recruitment will stop after 14 patients have been entered in order to confirm that IRESSA™ (gefitinib)has anti-tumour efficacy. If no patient out of 14 in a group has shown clinical benefit (ie an objective response (CR or PR) or stable disease (SD) for at least 24 weeks) then a clinical benefit rate of >20% can be ruled out with >95% certainty. If one or more of the objective response or stable disease (> 24 weeks) has been seen in the first 14 patients recruited in a group then recruitment to that group will recommence to a total of 27 patients. If 14 patients are entered into an arm but not all 14 patients are available for final analysis and the toxicity/safety and tolerability profile of the therapy is acceptable and documented and a clinical benefit is seen in the patients, enrolment of additional patients beyond the initial 14 may be made based on overall clinical assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • histological or cytological confirmation of breast cancer that is either

    • a primary tumour in a patient unfit for or who has declined surgery
    • advanced (locally or metastatic) disease
  • acquired resistance to tamoxifen or ER negative tumour
  • at least one measurable or assessable lesion
  • WHO performance status 0 - 2
  • life expectancy of 12 weeks or more

Exclusion Criteria:

  • more than one previous chemotherapy regimens for advanced disease
  • prior anthracycline chemotherapy (> 250 mg/m2 adriamycin)
  • radiotherapy completed within 14 days prior to Day 1 of treatment
  • incomplete healing from prior oncologic or other major surgery
  • signs of neurological symptoms consistent with spinal cord compression
  • any evidence of clinically active interstitial lung disease (patients with chronic stable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria
Time Frame: Assessed after 24 weeks
Assessed after 24 weeks
Clinical benefit (CR + PR + SD > 24 wks)
Time Frame: After 24 weeks of treatment
After 24 weeks of treatment
Frequency and severity of adverse events (AEs)
Time Frame: Assessed at each visit
Assessed at each visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Time to death
Time to death
Duration of response
Time Frame: Time to progression
Time to progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: R Robertson, MD, City Hospital, Nottingham , UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2009

Last Update Submitted That Met QC Criteria

April 21, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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