Breast Cancer
Conditions
Brief summary
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
Detailed description
All cases at the participating institutions.
Interventions
DRUGAromasin
25 mg table QD
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Postmenopausal women with breast cancer eligible for hormonal therapy.
Exclusion criteria
* Pregnant breast-feeding premenopausal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time-to-Progression (Early Breast Cancer) | 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 Without Recurrence/Metastasis (Early Breast Cancer) | 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). |
| Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) | 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. |
Countries
South Korea
Participant flow
Recruitment details
Participants were enrolled between June 2010 and June 2014 from 25 Korean health care centers.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 206 |
| Total | 206 |
Baseline characteristics
| Characteristic | Aromasin |
|---|---|
| Age, Continuous | 57.2 Years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 206 Participants |
| Sex: Female, Male Male | 0 Participants |
| Treatment Indication Adjuvant Therapy for Early Breast Cancer | 81 Participants |
| Treatment Indication Second-Line Therapy for Advanced Cancer | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 206 |
| serious Total, serious adverse events | 2 / 206 |
Outcome results
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.
Time frame: From the first dose of Aromasin through the end of the study for an average of 5.6 months
Population: Safety Analysis Set: included participants who received Aromasin at least once and were evaluated upon its related safety endpoints at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aromasin | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 25.24 Percentage of Participants |
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.
Time frame: At the end of the study, average of 5.6 months
Population: Efficacy Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aromasin | Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) | CR | 0.89 Percentage of Participants |
| Aromasin | Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) | PR | 4.46 Percentage of Participants |
| Aromasin | Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) | SD | 49.11 Percentage of Participants |
| Aromasin | Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) | PD | 45.54 Percentage of Participants |
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).
Time frame: At the end of the study, average of 5.6 months.
Population: Efficacy Analysis Set: included all participants who received Aromasin for at least 4 weeks in treatment of breast cancer and had efficacy data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aromasin | Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer) | 95.95 Percentage of Participants |
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.
Time frame: At the end of the study, average of 5.6 months
Population: 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.