IRESSA™ (Gefitinib) in Breast Cancer Patients

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. Identifier: NCT00632723
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : April 22, 2009
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: gefitinib (IRESSA™, ZD1839) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2001
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Intervention Details:
    Drug: gefitinib (IRESSA™, ZD1839)
    250 mg tablet; daily dose 500 mg daily
    Other Names:
    • IRESSA™
    • ZD1839

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

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Time to death ]
  2. Duration of response [ Time Frame: Time to progression ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00632723

Sponsors and Collaborators
Principal Investigator: R Robertson, MD City Hospital, Nottingham , UK

Responsible Party: Pauline Pert, Clinical Leader, AZ UK MC, AstraZeneca Identifier: NCT00632723     History of Changes
Other Study ID Numbers: 1839IL/0057
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
oestrogen receptor
ER negative tumours
epidermal growth factor receptor (EGFR)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action