Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255463
First received: November 17, 2005
Last updated: April 22, 2009
Last verified: April 2009
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Purpose
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Anastrazole Drug: Gefitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
Secondary Outcome Measures:
- Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
- Comparison of WHO and RECIST criteria,
- Exploratory biomarker studies involving genomics, metabolomics and proteomics.
| Estimated Enrollment: | 185 |
| Study Start Date: | January 2004 |
| Study Completion Date: | November 2005 |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Measurable (stage I-IIIB) non meta static non inflammatory breast cancer
- Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:
- Natural menopause with last menses > 1 year ago,
- Radiation induced oophorectomy with last menses > 1 year ago,
- Serum FSH and LH levels clearly in the postmenopausal range for the institution.
- Bilateral oophorectomy
Exclusion Criteria:
- Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,
- Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255463
Locations
| Czech Republic | |
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| Brno, Czech Republic | |
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| Chomutov, Czech Republic | |
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| Ostrava, Czech Republic | |
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| Ostrava - Poruba, Czech Republic | |
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| Praha 2, Czech Republic | |
| France | |
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| Clermont Ferrand, France | |
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| Montpellier Cedex 5, France | |
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| Tours Cedex, France | |
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| Villejuif Cedex, France | |
| Hungary | |
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| Budapest, Hungary | |
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| Debrecen, Hungary | |
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| Kecskemet, Hungary | |
| Portugal | |
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| Coimbra, Portugal | |
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| Funchal, Portugal | |
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| Lisboa, Portugal | |
| Spain | |
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| Santiago de Compostela, A Coruña, Spain | |
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| Jaen, Jaén, Spain | |
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| A Coruna, Spain | |
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| Sevilla, Spain | |
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| Valencia, Spain | |
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| Zaragoza, Spain | |
| Sweden | |
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| Göteborg, Sweden | |
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| Molndal, Sweden | |
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| Stockholm, Sweden | |
| United Kingdom | |
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| Chelmsford, Essex, United Kingdom | |
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| Bournemouth, United Kingdom | |
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| Croydon, United Kingdom | |
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| Dundee, United Kingdom | |
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| Leeds, United Kingdom | |
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| Liverpool, United Kingdom | |
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| London, United Kingdom | |
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| Manchester, United Kingdom | |
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| Newcastle Upon Tyne, United Kingdom | |
| Research Site | |
| Poole, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Iressa Medical Sciences Director, MD | AstraZeneca |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00255463 History of Changes |
| Other Study ID Numbers: | 1839IL/0223, D7913C00223 |
| Study First Received: | November 17, 2005 |
| Last Updated: | April 22, 2009 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Anastrozole Gefitinib Antineoplastic Agents, Hormonal |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013