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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00632723 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: gefitinib (IRESSA™, ZD1839) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Enrollment: | 54 |
Study Start Date: | April 2001 |
Study Completion Date: | October 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
histological or cytological confirmation of breast cancer that is either
Exclusion Criteria:
Responsible Party: | AstraZeneca ( Pauline Pert, Clinical Leader, AZ UK MC ) |
Study ID Numbers: | 1839IL/0057 |
Study First Received: | January 17, 2008 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00632723 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
oestrogen receptor ER negative tumours epidermal growth factor receptor (EGFR) |
Estrogens Skin Diseases Mitogens Breast Neoplasms |
Protein Kinase Inhibitors Tamoxifen Gefitinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Protein Kinase Inhibitors Gefitinib Pharmacologic Actions Breast Diseases |