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This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
All cases at the participating institutions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ajuvant group | adjuvant setting after two to three years of tamoxifen |
| |
| palliative group | palliative setting after progression of disease with anti-estrogen therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromasin | Drug | 25 mg table QD |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized. | From the first dose of Aromasin through the end of the study for an average of 5.6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer) | The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF). | At the end of the study, average of 5.6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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- Postmenopausal women diagnosed as estrogen-receptor positive early breast cancer, who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy OR postmenopausal women with breast cancer that has progressed following anti-estrogen therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Cheonan | Cheonan | Chungcheongnam-do | 330-721 | South Korea | ||
| Hallym University Sacred Heart Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants were enrolled between June 2010 and June 2014 from 25 Korean health care centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aromasin | Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Aromasin | Drug | 25 mg table QD |
|
|
| Time-to-Progression (Early Breast Cancer) | Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer. | At the end of the study, average of 5.6 months |
| Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) | The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions. | At the end of the study, average of 5.6 months |
| Anyang-si |
| Gyeonggi-do |
| 431-070 |
| South Korea |
| Soon Chun Hyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
| Myongji Hospital, Kwangdong Unversity College of Medicine | Goyang-si | Gyeonggi-do | 412-270 | South Korea |
| Wonkwang University School of Medicine and Hospital (WUH) | Iksan -si | Jeollabuk-do | 570-749 | South Korea |
| Asan Medical Center | Seoul | Korea | 138-736 | South Korea |
| Seoul National University Hospital (SNUH) | Seoul | Seoul | 110-744 | South Korea |
| Hwasun Hospital, Chonnam National University | Cheonnam | South Jeolla Province | 519-809 | South Korea |
| Inje University Busan Paik Hospital | Busan | 614-735 | South Korea |
| Yeung Nam University Hospital | Daegu | 705-717 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 463-707 | South Korea |
| Inha University Hospital | Incheon | 400-711 | South Korea |
| Cheil General Hospital & Women's Healthcare Center | Seoul | 100-380 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Severance Hospital, Yonsei University Health System, Yonsei Cancer Center | Seoul | 120-752 | South Korea |
| Samsung Medical Center | Seoul | 135 710 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| Asan Medical Center, University of Ulsan | Seoul | 138-736 | South Korea |
| Korea University Medical Center (KUMC) - Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 158-710 | South Korea |
| Ajou University Hospital | Suwon | 443-380 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aromasin | Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Treatment Indication | Number | Participants |
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| 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 of Participants With Treatment-Emergent Adverse Events (TEAEs) | All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized. | Safety Analysis Set: included participants who received Aromasin at least once and were evaluated upon its related safety endpoints at least once. | Posted | Number | Percentage of Participants | From the first dose of Aromasin through the end of the study for an average of 5.6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer) | The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF). | Efficacy Analysis Set: included all participants who received Aromasin for at least 4 weeks in treatment of breast cancer and had efficacy data available. | Posted | Number | Percentage of Participants | At the end of the study, average of 5.6 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Time-to-Progression (Early Breast Cancer) | Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer. | This outcome was planned to be analyzed in participants with early breast cancer in the efficacy analysis set. However, the analysis was not performed because the data of time-to-progression was not captured in the CRF. | Posted | At the end of the study, average of 5.6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) | The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions. | Efficacy Analysis Set. | Posted | Number | Percentage of Participants | At the end of the study, average of 5.6 months |
|
From first dose of Aromasin through the end of the study for an average of 5.6 months.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
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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 | Aromasin | Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity. | 2 | 206 | 40 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONDITION AGGRAVATED | General disorders | WHO-ART v092 | Non-systematic Assessment |
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| ASTHENIA | General disorders | WHO-ART v092 | Non-systematic Assessment |
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| HEPATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART v092 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEG PAIN | General disorders | WHO-ART v092 | Non-systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | WHO-ART v092 | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | WHO-ART v092 | Non-systematic Assessment |
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| BILIRUBINAEMIA | Hepatobiliary disorders | WHO-ART v092 | Non-systematic Assessment |
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| SERUM GLUTAMIC OXALOACETIC TRANSAMINASE INCREASED | Hepatobiliary disorders | WHO-ART v092 | Non-systematic Assessment |
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| SERUM GLUTAMIC PYRUVIC TRANSAMINASE INCREASED | Hepatobiliary disorders | WHO-ART v092 | Non-systematic Assessment |
| |
| PHOSPHATASE ALKALINE INCREASED | Metabolism and nutrition disorders | WHO-ART v092 | Non-systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | WHO-ART v092 | Non-systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | WHO-ART v092 | Non-systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | WHO-ART v092 | Non-systematic Assessment |
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| SKELETAL PAIN | Musculoskeletal and connective tissue disorders | WHO-ART v092 | Non-systematic Assessment |
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| ANOREXIA | Psychiatric disorders | WHO-ART v092 | Non-systematic Assessment |
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| DEPRESSION | Psychiatric disorders | WHO-ART v092 | Non-systematic Assessment |
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| INSOMNIA | Psychiatric disorders | WHO-ART v092 | Non-systematic Assessment |
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| COUGHING | Respiratory, thoracic and mediastinal disorders | WHO-ART v092 | Non-systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | WHO-ART v092 | Non-systematic Assessment |
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| PHARYNGITIS | Respiratory, thoracic and mediastinal disorders | WHO-ART v092 | Non-systematic Assessment |
| |
| LYMPHOEDEMA | Blood and lymphatic system disorders | WHO-ART v092 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.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 |
|---|---|
| C056516 | exemestane |
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