Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00255463
• Collaborator: (none)
• Enrollment: 185
• Locations: 34
• Duration (Months): 22
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Anastrazole; Drug: Gefitinib	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Jan 1, 2004
• Actual Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. To determine and compare changes in proliferation marker at 16 weeks in the treatment groups []

Secondary Outcome Measures

1. Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate. []

2. Comparison of WHO and RECIST criteria, []

3. Exploratory biomarker studies involving genomics, metabolomics and proteomics. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Brno		Czech Republic
2	Research Site	Chomutov		Czech Republic
3	Research Site	Ostrava - Poruba		Czech Republic
4	Research Site	Ostrava		Czech Republic
5	Research Site	Praha 2		Czech Republic
6	Research Site	Clermont Ferrand		France
7	Research Site	Montpellier Cedex 5		France
8	Research Site	Tours Cedex		France
9	Research Site	Villejuif Cedex		France
10	Research Site	Budapest		Hungary
11	Research Site	Debrecen		Hungary
12	Research Site	Kecskemet		Hungary
13	Research Site	Coimbra		Portugal
14	Research Site	Funchal		Portugal
15	Research Site	Lisboa		Portugal
16	Research Site	Santiago de Compostela	A Coruña	Spain
17	Research Site	Jaen	Jaén	Spain
18	Research Site	A Coruna		Spain
19	Research Site	Sevilla		Spain
20	Research Site	Valencia		Spain
21	Research Site	Zaragoza		Spain
22	Research Site	Göteborg		Sweden
23	Research Site	Molndal		Sweden
24	Research Site	Stockholm		Sweden
25	Research Site	Chelmsford	Essex	United Kingdom
26	Research Site	Bournemouth		United Kingdom
27	Research Site	Croydon		United Kingdom
28	Research Site	Dundee		United Kingdom
29	Research Site	Leeds		United Kingdom
30	Research Site	Liverpool		United Kingdom
31	Research Site	London		United Kingdom
32	Research Site	Manchester		United Kingdom
33	Research Site	Newcastle Upon Tyne		United Kingdom
34	Research Site	Poole		United Kingdom

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: AstraZeneca Iressa Medical Sciences Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00255463
• Other Study ID Numbers: 1839IL/0223; D7913C00223
• First Posted: Nov 21, 2005
• Last Update Posted: Apr 23, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Breast Neoplasms; Gefitinib; Anastrozole

Study Results

No Results Posted as of Apr 23, 2009