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IRESSA™ (Gefitinib) in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00632723
First received: January 17, 2008
Last updated: April 21, 2009
Last verified: April 2009
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: gefitinib (IRESSA™, ZD1839)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria [ Time Frame: Assessed after 24 weeks ] [ Designated as safety issue: No ]
  • Clinical benefit (CR + PR + SD > 24 wks) [ Time Frame: After 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events (AEs) [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Time to death ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Time to progression ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: April 2001
Study Completion Date: October 2005
Intervention Details:
    Drug: gefitinib (IRESSA™, ZD1839)
    250 mg tablet; daily dose 500 mg daily
    Other Names:
    • IRESSA™
    • ZD1839
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632723

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: R Robertson, MD City Hospital, Nottingham , UK
  More Information

No publications provided

Responsible Party: Pauline Pert, Clinical Leader, AZ UK MC, AstraZeneca
ClinicalTrials.gov Identifier: NCT00632723     History of Changes
Other Study ID Numbers: 1839IL/0057
Study First Received: January 17, 2008
Last Updated: April 21, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on May 23, 2013