Clinical trial · Observational
Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 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)
This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its 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 |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromasin | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 1
- interventionNames
- Drug: Aromasin
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- Baseline up to Month 36
- description
- Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Secondary outcomes (7)
- measure
- Number of Participants With Concomitant Morbidities
- timeFrame
- Baseline up to Month 36
- description
- Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
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 histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * Patients who are disease-free after 2 to 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). * Metastatic breast cancer or a contra lateral tumour. * Other concomitant adjuvant endocrine therapy. * Other 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