Clinical trial NCT00632723: IRESSA™ (Gefitinib) in Breast Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: oestrogen receptor
ER negative tumours
epidermal growth factor receptor (EGFR)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-11
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria
timeFrame: Assessed after 24 weeks
measure: Clinical benefit (CR + PR + SD > 24 wks)
timeFrame: After 24 weeks of treatment
measure: Frequency and severity of adverse events (AEs)
timeFrame: Assessed at each visit
Secondary outcomes:
measure: Progression-free survival
timeFrame: Time to death
measure: Duration of response
timeFrame: Time to progression
Other outcomes:
Locations:
Study officials:
affiliation: City Hospital, Nottingham , UK
name: R Robertson, MD
role: PRINCIPAL_INVESTIGATOR
References: