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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00252811 |
This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week after surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II, Randomised, Double-Blind, Placebocontrolled Study To Investigate The Effects Of ZD1839 (IRESSA™) On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery |
Estimated Enrollment: | 60 |
Study Start Date: | February 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Research Site | |
Milan, Italy |
Study Director: | AstraZeneca Italy Medical Director, MD | AstraZeneca |
Principal Investigator: | A Decensi, MD | Istituto Europeo di Oncologia di Milano |
Study ID Numbers: | D7913C00509, 1839IL/0509 |
Study First Received: | November 1, 2005 |
Last Updated: | January 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00252811 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Progesterone Skin Diseases Breast Neoplasms Gefitinib Breast Diseases |
Neoplasms Neoplasms by Site |