Clinical trial · Observational
Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
A Non-Interventional Observational Study Evaluating The Effects Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy On Safety In Postmenopausal And Hormone Receptors Positive Early Breast Cancer Patients
NCT01155063CI-TRIAL-00008177terminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See Detailed Description
Summary
Brief summary (as posted)
Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromasin (exemestane) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Main Group
- description
- Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
- interventionNames
- Other: Aromasin (exemestane)
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- Month 0 up to Month 36 or early withdrawal
- description
- An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.
Secondary outcomes (6)
- measure
- Number of Participants With Concomitant Morbidities
- timeFrame
- Month 0 up to Month 36 or early withdrawal
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal females. * Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment. * Patients whose tumour was estrogen receptor positive (ER+). * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: * Patients for whom Aromasin® treatment is contraindicated (see SPC). * Presence of metastasis or a contra lateral tumour. * Other adjuvant endocrine therapy. * Another concomitant antineoplastic treatment. * Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.