IRESSA™ (Gefitinib) in Breast Cancer Patients

NCT ID: NCT00632723

Last Updated: 2009-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2005-10-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

gefitinib (IRESSA™, ZD1839)

250 mg tablet; daily dose 500 mg daily

Intervention Type: DRUG

Other Intervention Names

IRESSA™; ZD1839

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

AstraZeneca

Principal Investigators

R Robertson, MD

Role: PRINCIPAL_INVESTIGATOR

City Hospital, Nottingham , UK

Other Identifiers

1839IL/0057

Identifier Type: -

Identifier Source: org_study_id