Full Text View
Tabular View
No Study Results Posted
Related Studies
IRESSA™ (Gefitinib) in Breast Cancer Patients
This study has been completed.
First Received: January 17, 2008   Last Updated: April 21, 2009   History of Changes
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00632723
  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 II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:


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

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

Study placed in the following topic categories:
Estrogens
Skin Diseases
Mitogens
Breast Neoplasms
Protein Kinase Inhibitors
Tamoxifen
Gefitinib
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Breast Neoplasms
Enzyme Inhibitors
Protein Kinase Inhibitors
Gefitinib
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009