Breast Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Tamoxifen | Anastrazole (Arimidex) | Goserelin acetate (Zoladex)
INN of investigational material :
Therapeutic category code : 429 Other antitumor agent
Sponsors
AstraZeneca
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 20 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Inclusion Criteria: -Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provide written informed consent Exclusion Criteria: -Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/Efficacy Primary Outcome Measures: -The primary objective of this study is to compare the tumour response rate between an anastrozole patient group and a tamoxifen group, during 24 weeks pre-operative administration, for premenopausal breast cancer patients receiving Zoladex 3.6mg/month [ Time Frame: Assessed after 24 weeks of treatment ] [ Designated as safety issue: No ]Secondary Outcome Measures: -Safety of anastrozole and tamoxifen groups by: adverse events, lab. tests, blood pressure, pulse rate, WHO performance status and change in bone mineral density and bone turnover markers. Additional efficacy markers [ Time Frame: Assessed after 24 weeks of treatment ] [ Designated as safety issue: Yes ] | — |
Outcome results
None listed