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| ID | Type | Description | Link |
|---|---|---|---|
| 9238IL/0057 |
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To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Anastrozole Monotherapy |
|
| 2 | Experimental | Fulvestrant Monotherapy |
|
| 3 | Experimental | Anastrozole + Fulvestrant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | 500 mg intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score. | For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) |
| Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score. | For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) |
| Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index. | For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nottingham | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497452 | Derived | Robertson JF, Dixon JM, Sibbering DM, Jahan A, Ellis IO, Channon E, Hyman-Taylor P, Nicholson RI, Gee JM. A randomized trial to assess the biological activity of short-term (pre-surgical) fulvestrant 500 mg plus anastrozole versus fulvestrant 500 mg alone or anastrozole alone on primary breast cancer. Breast Cancer Res. 2013 Mar 5;15(2):R18. doi: 10.1186/bcr3393. |
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121 patients had baseline biopsy and were randomised 1:1:1. 120 patients received 14 to 21 days therapy. Surgery was actually performed between day 13 and 28 and a tumour sample was taken. Safety data is presented for all 120 patients who received therapy. The demography data are summarized for the population who had a usable tumour sample.
Postmenopausal women with oestrogen receptor positive breast cancer, awaiting curative-intent surgery were recruited to 4 medical centres within the UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrant | Fulvestrant 500 mg once monthly injection |
| FG001 | Fulvestrant + Anastrozole | Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Anastrazole | Drug | oral tablet |
|
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| FG002 | Anastrozole | Anastrozole 1 mg once daily tablet |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant | Fulvestrant 500 mg once monthly injection |
| BG001 | Fulvestrant + Anastrozole | Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet |
| BG002 | Anastrozole | Anastrozole 1 mg once daily tablet |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score. | For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 | Posted | Mean | Standard Error | Percentage change from baseline | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) |
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| Primary | Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score. | For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 | nine patients with PgR=0 at baseline were excluded from analysis of PgR because the question of medical interest was the effect of treatment on PgR positive patients. | Posted | Mean | Standard Error | Percentage change from baseline | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) |
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| Primary | Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index. | For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 | Posted | Mean | Standard Error | Percentage change from baseline | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) |
|
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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 | Fulvestrant | Fulvestrant 500 mg once monthly injection | 0 | 40 | 18 | 40 | ||
| EG001 | Fulvestrant + Anastrozole | Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet | 3 | 40 | 13 | 40 | ||
| EG002 | Anastrozole | Anastrozole 1 mg once daily tablet | 2 | 40 | 17 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Unevaluable Event | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection Site Rash | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Unevaluable Event | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
AZ shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time request that submission for publication or disclosure of the manuscript be delayed for no more than an additional 45 days in order for AZ to file patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 60 - 69 years |
|
| 70 - 79 years |
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| 80 - 89 years |
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| Not available |
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| Male |
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| Participants |
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