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
N/A
N/A
Female
Breast Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
Principal Investigator
AstraZeneca Iressa Medical Sciences Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Sweden: Medical Products Agency
Study ID:
1839IL/0223
NCT ID:
NCT00255463
Start Date:
January 2004
Completion Date:
November 2005
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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