Clinical trial · Observational
Real-world Data in Patients With Breast Cancer Treated With Abemaciclib
Real-world Clinical Outcome and Toxicity Data in Patients With Breast Cancer Treated With Abemaciclib Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group
NCT04985058CI-TRIAL-00118792ENDURANCErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive, HER2-negative advanced breast cancer.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients with breast cancer randomised in arm A of digital platform
- description
- Patients with breast cancer treated with abemaciclib in combination with endocrine treatment and randomised in Arm A of the digital platform. Patients randomised in arm A will receive a an acknowledgement and suggestion to stay in contact with their clinician.
- label
- Patients with breast cancer randomised in arm B of digital platform
- description
- Patients with breast cancer treated with abemaciclib in combination with endocrine treatment and randomised in Arm B of the digital platform. Patients randomised in arm A will receive a an acknowledgement and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported.
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Through the completion of the study, for an average of 6 months
- description
- the time from treatment initiation to either the first documented disease progression or death from any cause
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed HR-positive, HER2-negative breast cancer * Treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology * 18 years or older * Any menopausal status * Treatment with abemaciclib in combination with endocrine therapy * Any endocrine therapy * At least two months of treatment with abemaciclib
References
Publications (1)
- DERIVEDFountzilas E, Aravantinou-Fatorou E, Dadouli K, Economopoulou P, Tryfonopoulos D, Vernadou A, Vorrias E, Vagionas A, Nikolaidi A, Karageorgopoulou S, Koumarianou A, Boukovinas I, Mauri D, Kokkali S, Christopoulou A, Tsoukalas N, Assi A, Spathas N, Kosmidis P, Koutras A, Fountzilas G, Psyrri A. Real-World Toxicity and Effectiveness Study of Abemaciclib in Greek Patients with Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: A Multi-Institutional Study. Cancers (Basel). 2025 Jul 31;17(15):2543. doi: 10.3390/cancers17152543. PMID 40805239