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Completed

NCT Number: NCT00255463

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrazole

Drug

Gefitinib

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Nov 21, 2005
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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