Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
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| ClinicalTrials.gov Identifier: NCT01047358 |
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Recruitment Status :
Completed
First Posted : January 12, 2010
Results First Posted : June 9, 2015
Last Update Posted : October 8, 2015
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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Brief Summary:
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer | Drug: Aromasin |
| Study Type : | Observational |
| Actual Enrollment : | 206 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer |
| Study Start Date : | June 2010 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | June 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Exemestane
| Group/Cohort | Intervention/treatment |
|---|---|
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ajuvant group
adjuvant setting after two to three years of tamoxifen
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Drug: Aromasin
25 mg table QD
Other Name: exemestane |
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palliative group
palliative setting after progression of disease with anti-estrogen therapy
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Drug: Aromasin
25 mg table QD
Other Name: exemestane |
Primary Outcome Measures :
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From the first dose of Aromasin through the end of the study for an average of 5.6 months ]All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.
Secondary Outcome Measures :
- Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer) [ Time Frame: At the end of the study, average of 5.6 months. ]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).
- Time-to-Progression (Early Breast Cancer) [ Time Frame: At the end of the study, average of 5.6 months ]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.
- Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) [ Time Frame: At the end of the study, average of 5.6 months ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
- 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.
Criteria
Inclusion Criteria:
- - Postmenopausal women with breast cancer eligible for hormonal therapy.
Exclusion Criteria:
- Pregnant breast-feeding premenopausal.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047358
Locations
Show 22 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01047358 |
| Other Study ID Numbers: |
A5991089 |
| First Posted: | January 12, 2010 Key Record Dates |
| Results First Posted: | June 9, 2015 |
| Last Update Posted: | October 8, 2015 |
| Last Verified: | October 2015 |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Exemestane Antineoplastic Agents Aromatase Inhibitors |
Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |