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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00255463
• Date of registration: 17/11/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
• Scientific 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
• Date of first enrolment: January 2004
• Target sample size: 185
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00255463
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Czech Republic, France, Hungary, Portugal, Spain, Sweden, United Kingdom

Contacts

• Name: AstraZeneca Iressa Medical Sciences Director, MD
• Affiliation: AstraZeneca

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Gefitinib

Drug: Anastrazole

Primary Outcome(s)

To determine and compare changes in proliferation marker at 16 weeks in the treatment groups

Secondary Outcome(s)

Comparison of WHO and RECIST criteria,

Exploratory biomarker studies involving genomics, metabolomics and proteomics.

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

Secondary ID(s)

1839IL/0223

D7913C00223

Source(s) of Monetary Support

Please refer to primary and secondary sponsors