Clinical trial NCT00605267: Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
Official title: Multi-centre, Randomised, Double-blind, Parallel-group Study to Compare Efficacy and Safety Between Anastrozole (ZD1033) and Tamoxifen in Pre- and Post-operative Administration Under Goserelin Acetate Treatment for Premenopausal Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Breast Neoplasms
Tumors or cancer of the human BREAST
Tumor or cancer of the human MAMMARY GLAND
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 197
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients


Eligibility criteria: Inclusion Criteria:

* Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided 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).

Primary outcomes:
measure: Best Overall Response Rate (BORR) (Calliper)
timeFrame: 24 weeks
measure: Best Overall Response Rate (BORR) (US)
timeFrame: 24 weeks
measure: Best Overall Response Rate (BORR) (MRI/CT)
timeFrame: 24 weeks
Secondary outcomes:
measure: Bone Mineral Density (BMD) Lumbar Spine
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Bone Mineral Density (BMD) Cervical Thighbone
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Bone Turnover Marker (BAP) EIA Method
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Bone Turnover Marker (BAP) CLEIA Method
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Bone Turnover Marker (NTX)
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Serum Oestrone (E1) Concentrations
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Serum Oestradiol (E2) Concentrations
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Oestrogen Receptor (ER) Status
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Progesterone Receptor (PgR) Status
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Human Epidermal Growth Factor Receptor 2 (HER2) Status
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Histopathological Response Rate (HRR)
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Endocrine Subscale (ES)
timeFrame: Assessed at baseline and after 24 weeks of treatment
measure: Anastrozole Plasma Concentrations (Cmin)
timeFrame: Assessed at week 12
Other outcomes:
Locations:
city: Hakata
country: Japan
facility: Research Site
state: Fukuoka
city: Kumamoto
country: Japan
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
Study officials:
affiliation: Clinical
name: Toshiyuki Kihara
role: STUDY_DIRECTOR
References:
citation: Masuda N, Sagara Y, Kinoshita T, Iwata H, Nakamura S, Yanagita Y, Nishimura R, Iwase H, Kamigaki S, Takei H, Noguchi S. Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. Lancet Oncol. 2012 Apr;13(4):345-52. doi: 10.1016/S1470-2045(11)70373-4. Epub 2012 Jan 20.