Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer
January 25, 2011 updated by: AstraZeneca
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
The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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the complete pathological response rate in the two study groups at trial closure
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Secondary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AstraZeneca Oncology Medical Director, MD, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (ACTUAL)
May 1, 2007
Study Completion (ACTUAL)
May 1, 2007
Study Registration Dates
First Submitted
October 14, 2005
First Submitted That Met QC Criteria
October 14, 2005
First Posted (ESTIMATE)
October 17, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
January 27, 2011
Last Update Submitted That Met QC Criteria
January 25, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1839IL/0712
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.