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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- Best Overall Response Rate (BORR) (Calliper)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- 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 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).
Arms & Interventions
1
Tamoxifen
Intervention: Tamoxifen (Drug)
1
Tamoxifen
Intervention: Goserelin acetate (Zoladex) (Drug)
2
Anastrazole (Arimidex)
Intervention: Anastrazole (Arimidex) (Drug)
2
Anastrazole (Arimidex)
Intervention: Goserelin acetate (Zoladex) (Drug)
Outcomes
Primary Outcomes
Best Overall Response Rate (BORR) (Calliper)
Time Frame: 24 weeks
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement). CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Best Overall Response Rate (BORR) (US)
Time Frame: 24 weeks
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement). CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Best Overall Response Rate (BORR) (MRI/CT)
Time Frame: 24 weeks
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement). CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary Outcomes
- Bone Mineral Density (BMD) Lumbar Spine(Assessed at baseline and after 24 weeks of treatment)
- Bone Turnover Marker (BAP) EIA Method(Assessed at baseline and after 24 weeks of treatment)
- Serum Oestrone (E1) Concentrations(Assessed at baseline and after 24 weeks of treatment)
- Bone Mineral Density (BMD) Cervical Thighbone(Assessed at baseline and after 24 weeks of treatment)
- Bone Turnover Marker (NTX)(Assessed at baseline and after 24 weeks of treatment)
- Serum Oestradiol (E2) Concentrations(Assessed at baseline and after 24 weeks of treatment)
- Human Epidermal Growth Factor Receptor 2 (HER2) Status(Assessed at baseline and after 24 weeks of treatment)
- Histopathological Response Rate (HRR)(Assessed at baseline and after 24 weeks of treatment)
- Progesterone Receptor (PgR) Status(Assessed at baseline and after 24 weeks of treatment)
- Anastrozole Plasma Concentrations (Cmin)(Assessed at week 12)
- Bone Turnover Marker (BAP) CLEIA Method(Assessed at baseline and after 24 weeks of treatment)
- Oestrogen Receptor (ER) Status(Assessed at baseline and after 24 weeks of treatment)
- Functional Assessment of Cancer Therapy-Breast (FACT-B)(Assessed at baseline and after 24 weeks of treatment)
- Endocrine Subscale (ES)(Assessed at baseline and after 24 weeks of treatment)