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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria

Outcome Time Frame:

Assessed after 24 weeks

Safety Issue:

No

Principal Investigator

R Robertson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City Hospital, Nottingham , UK

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

1839IL/0057

NCT ID:

NCT00632723

Start Date:

April 2001

Completion Date:

October 2005

Related Keywords:

  • Breast Cancer
  • oestrogen receptor
  • ER negative tumours
  • epidermal growth factor receptor (EGFR)
  • Breast Neoplasms

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