Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Goserelin

Anastrozole

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Aromatase Inhibitors

Enzyme Inhibitors

Anastrazole (Arimidex)

Goserelin acetate (Zoladex)

Toshiyuki Kihara

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

Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

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

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.

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.

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.

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.

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.

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method

Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks

Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.

Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.

ER status in the ITT population is categorized as Positive or Negative

PgR status in the ITT population is categorized as Positive or Negative.

HER2 status in the ITT population is categorized as Positive or Negative

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)

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.

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

Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.

AstraZeneca

One subject voluntarily discontinued prior to receiving treatment to Tamoxifen

Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection

Anastrozole 1 mg

Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection

Tamoxifen 20 mg

Total

20-29 years

30-39 years

40-49 years

50-59 years

Age, Customized

Sex: Female, Male

Gerard Lynch

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.

At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter

Best Overall Response Rate (BORR) (Calliper)

Best Overall Response Rate (BORR) (US)

Best Overall Response Rate (BORR) (MRI/CT)

The standard BMD value is defined by Japanese Osteoporosis Society in the table of reference values showing the mean for the age, gender, race, skeletal site, and densitometer measurement units was used. Then the formula was used at each measurement data: BMD(%) = Patient's BMD / standard BMD) x 100

Bone Mineral Density (BMD) Lumbar Spine

Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks - BMD percentage at baseline

Bone Mineral Density (BMD) Cervical Thighbone

Bone Turnover Marker (BAP) EIA Method

Bone Turnover Marker (BAP) CLEIA Method

Bone Turnover Marker (NTX)

Serum Oestrone (E1) Concentrations

Serum Oestradiol (E2) Concentrations

Baseline Positive & 24 weeks Negative

Baseline Positive & 24 weeks Positive

Baseline Negative & 24 weeks Negative

Baseline Negative & 24 weeks Positive

Oestrogen Receptor (ER) Status

Progesterone Receptor (PgR) Status

Human Epidermal Growth Factor Receptor 2 (HER2) Status

Histopathological Response Rate (HRR)

Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.

PWB, FWB and BCS were assessed in this study. TOI was a total of PWB, FWB and BCS.

Spots Global Cancer Trial Database for Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

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