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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00239343 |
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Date of registration:
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14/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer
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Scientific title:
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Randomised Placebo-controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3) Oestrogen Receptor Negative Breast Cancer |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00239343 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Norway
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Sweden
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Contacts
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Name:
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AstraZeneca Oncology Medical Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- histologically confirmed oestrogen receptor negative primary breast cancer, tumour
stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1.
Exclusion Criteria:
- any prior anticancer therapy including gefitinib (Iressa®), epirubicin
(Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer,
any evidence of clinically active interstitial lung disease , other co-existing
malignancies or malignancies diagnosed within the last 5 years with the exception of
basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: gefitinib
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Primary Outcome(s)
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the complete pathological response rate in the two study groups at trial closure
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Secondary Outcome(s)
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complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population
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Secondary ID(s)
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1839IL/0712
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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