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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Tamoxifen |
|
| 2 | Experimental | Anastrazole (Arimidex) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 20 mg once daily oral dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at baseline and after 24 weeks of treatment |
| Bone Mineral Density (BMD) Cervical Thighbone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshiyuki Kihara | Clinical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hakata | Fukuoka | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22265697 | Derived | 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. |
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A total of 197 participants were recruited into this study and 98 were randomized to Anastrozole (20 mg once daily oral dose) and 99 were randomized to Tamoxifen (1 mg once daily oral dose) with one subject voluntarily discontinuing prior to receiving treatment Tamoxifen.
Participants were recruited from 4 research sites in Japan: Hakata (Fukuoka), Kumamoto (Kumamoto), Nagoya (Nagoya), Osaka (Osaka). The study initiation date was October 2007 and the study completion date was January 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anastrozole 1 mg | Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection |
| FG001 | Tamoxifen 20 mg | Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anastrozole 1 mg | Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection |
| BG001 | Tamoxifen 20 mg | Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Number | Percentage of Participants | 24 weeks |
|
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One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anastrozole 1 mg | Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Benign Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D000077384 | Anastrozole |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Anastrazole (Arimidex) | Drug | 1 mg once daily oral dose |
|
|
| Goserelin acetate (Zoladex) | Drug | 3.6mg/month depot injection |
|
|
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. |
| 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 | 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 | 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 | 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. | 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. | 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 | 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. | 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 | 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) | 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. | 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 | 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. | Assessed at week 12 |
| Kumamoto |
| Kumamoto |
| Japan |
| Research Site | Nagoya | Nagoya | Japan |
| Research Site | Osaka | Osaka | Japan |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
| OG001 | Tamoxifen 20 mg | Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection |
|
|
| Primary | 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. | Posted | Number | Participants | 24 weeks |
|
|
|
| Primary | 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. | Posted | Number | Percentage of Participants | 24 weeks |
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | PercentageBMD=Patient's BMD/standard BMD | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | 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. | Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks - BMD percentage at baseline | Posted | Mean | Standard Deviation | PercentageBMD=Patient'sBMD/standard BMD) | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Bone Turnover Marker (BAP) EIA Method | Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method | Posted | Mean | Standard Deviation | U/L | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Bone Turnover Marker (BAP) CLEIA Method | Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method | Posted | Mean | Standard Deviation | ug/L | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Bone Turnover Marker (NTX) | Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks | Posted | Mean | Standard Deviation | nmolBCE(Bone Collagen Equivalent) /L | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Serum Oestrone (E1) Concentrations | Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks. | Posted | Mean | Standard Deviation | Ratio | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Serum Oestradiol (E2) Concentrations | Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks. | Posted | Mean | Standard Deviation | Ratio | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Oestrogen Receptor (ER) Status | ER status in the ITT population is categorized as Positive or Negative | Posted | Number | Participants | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Progesterone Receptor (PgR) Status | PgR status in the ITT population is categorized as Positive or Negative. | Posted | Number | Participants | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Human Epidermal Growth Factor Receptor 2 (HER2) Status | HER2 status in the ITT population is categorized as Positive or Negative | Posted | Number | Participants | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | 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) | Posted | Number | Percentage of Participants | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Trial Outcome Index (TOI) (Prorated) | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | 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 | Difference of Endocrine Subscale (ES) = ES at 24 weeks - ES at baseline. | Posted | Mean | Standard Deviation | ES score | Assessed at baseline and after 24 weeks of treatment |
|
|
|
| Secondary | Anastrozole Plasma Concentrations (Cmin) | Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations. | Posted | Geometric Mean | Full Range | ng/mL | Assessed at week 12 |
|
|
|
| 1 |
| 98 |
| 87 |
| 98 |
| EG001 | Tamoxifen 20 mg | Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection | 0 | 98 | 84 | 98 |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Menopausal Symptoms | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| Baseline Negative & 24 weeks Negative |
|
| Baseline Negative & 24 weeks Positive |
|
| Baseline Negative & 24 weeks Negative |
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| Baseline Negative & 24 weeks Positive |
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| Baseline Negative & 24 weeks Negative |
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| Baseline Negative & 24 weeks Positive |
|