IRESSA™ (Gefitinib) in Breast Cancer Patients

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632723
• Other study ID #: 1839IL/0057
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2008
• Last updated: April 21, 2009
• Start date: April 2001
• Est. completion date: October 2005

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria		Assessed after 24 weeks	No
Primary	Clinical benefit (CR + PR + SD > 24 wks)		After 24 weeks of treatment	No
Primary	Frequency and severity of adverse events (AEs)		Assessed at each visit	No
Secondary	Progression-free survival		Time to death	No
Secondary	Duration of response		Time to progression	No