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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
197
Research Site
Hakata, Fukuoka, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Nagoya, Nagoya, Japan
Research Site
Osaka, Osaka, Japan
Best Overall Response Rate (BORR) (Calliper)
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.
Time frame: 24 weeks
Best Overall Response Rate (BORR) (US)
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.
Time frame: 24 weeks
Best Overall Response Rate (BORR) (MRI/CT)
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.
Time frame: 24 weeks
Bone Mineral Density (BMD) Lumbar Spine
Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.
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Time frame: Assessed at baseline and after 24 weeks of treatment
Bone Mineral Density (BMD) Cervical Thighbone
Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone.
Time frame: Assessed at baseline and after 24 weeks of treatment
Bone Turnover Marker (BAP) EIA Method
Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method
Time frame: Assessed at baseline and after 24 weeks of treatment
Bone Turnover Marker (BAP) CLEIA Method
Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method
Time frame: Assessed at baseline and after 24 weeks of treatment
Bone Turnover Marker (NTX)
Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks
Time frame: Assessed at baseline and after 24 weeks of treatment
Serum Oestrone (E1) Concentrations
Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
Time frame: Assessed at baseline and after 24 weeks of treatment
Serum Oestradiol (E2) Concentrations
Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
Time frame: Assessed at baseline and after 24 weeks of treatment
Oestrogen Receptor (ER) Status
ER status in the ITT population is categorized as Positive or Negative
Time frame: Assessed at baseline and after 24 weeks of treatment
Progesterone Receptor (PgR) Status
PgR status in the ITT population is categorized as Positive or Negative.
Time frame: Assessed at baseline and after 24 weeks of treatment
Human Epidermal Growth Factor Receptor 2 (HER2) Status
HER2 status in the ITT population is categorized as Positive or Negative
Time frame: Assessed at baseline and after 24 weeks of treatment
Histopathological Response Rate (HRR)
Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)
Time frame: Assessed at baseline and after 24 weeks of treatment
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B. FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale). Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.
Time frame: Assessed at baseline and after 24 weeks of treatment
Endocrine Subscale (ES)
Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life. Score range: 0-72
Time frame: Assessed at baseline and after 24 weeks of treatment
Anastrozole Plasma Concentrations (Cmin)
Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.
Time frame: Assessed at week 12