N/A
N=206
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01047358 ↗Enrolled (actual)
206
Serious AEs
1.0%
Results posted
Jun 2015
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 25.24 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Aromasin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
25.24 | — |
| SECONDARY Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer) |
95.95 | — |
| SECONDARY Time-to-Progression (Early Breast Cancer) |
— | — |
| SECONDARY Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) |
0.89; 4.46; 49.11; 45.54 | — |
Summary
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
Eligibility Criteria
Inclusion Criteria
- - Postmenopausal women with breast cancer eligible for hormonal therapy.
Exclusion Criteria
- Pregnant breast-feeding premenopausal.
Data sourced from ClinicalTrials.gov (NCT01047358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.