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OpenTrials
Completed

NCT Number: NCT00632723

IRESSA™ (Gefitinib) in Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gefitinib (IRESSA™, ZD1839)

Drug

250 mg tablet; daily dose 500 mg daily

Other names: IRESSA™, ZD1839

Primary outcomes

  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 outcomes

  1. Progression-free survival

    Time frame: Time to death

  2. Duration of response

    Time frame: Time to progression

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2005
First posted
Mar 11, 2008
Registry last updated
Apr 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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