Clinical trial · Observational
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy
- 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 termination reason in detailed description.
Summary
Brief summary (as posted)
The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.
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 |
|---|---|---|---|
| Invasive Early Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromasin | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Aromasin
- description
- All patients included in the study
- interventionNames
- Drug: Aromasin
Primary outcomes (2)
- measure
- Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
- timeFrame
- Baseline up to 28 days after last dose
- description
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal females, defined as one from the next : 1. Natural menopause \>/=1 year, 2. Surgical ovariectomy, 3. Chemotherapy-induced amenorrhoea \>/=2 years. * 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 SmPC). * 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. * The patients are not supposed to participate to any other trial during all the study period.
References
Publications (0)
Data not yet available