Breast Cancer
Conditions
Brief summary
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
Interventions
DRUGAnastrazole
DRUGGefitinib
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine and compare changes in proliferation marker at 16 weeks in the treatment groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Czechia, France, Hungary, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed