Clinical trial · Observational
Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy
Registry Study of Patients With Advanced Breast Cancer Treated With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group
NCT04133207CI-TRIAL-00050046HeCOG/CDKicompletedClinicalTrials.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 CDKi 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 Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with advanced HR-positive breast cancer
- description
- patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology
Primary outcomes (1)
- measure
- Toxicity rates
- timeFrame
- Time Frame: through the completion of the study, up to 2 years
- description
- Rates of adverse events from the combination of CDKi and endocrine therapy
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Time Frame: from the date of treatment start until death from any cause or date of last contact whichever occurred first, assessed up to 60 months
- description
- Overall survival was defined as the time from diagnosis until death from any cause or last follow-up
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * Αny menopausal status is allowed * HR-positive/HER2-negative advanced breast cancer * Patients treated with CDKi in combination with endocrine therapy for their advanced breast cancer * Combinations of CDKi with any endocrine therapy are allowed * More than two months of treatment with a CDKi is mandatory Exclusion criteria: • Treatment with CDKi as (neo)adjuvant treatment
References
Publications (1)
- DERIVEDFountzilas E, Koliou GA, Vozikis A, Rapti V, Nikolakopoulos A, Boutis A, Christopoulou A, Kontogiorgos I, Karageorgopoulou S, Lalla E, Tryfonopoulos D, Boukovinas I, Rapti C, Nikolaidi A, Karteri S, Moirogiorgou E, Binas I, Mauri D, Aravantinos G, Zagouri F, Saridaki Z, Psyrri A, Bafaloukos D, Koumarianou A, Res E, Linardou H, Mountzios G, Razis E, Fountzilas G, Koumakis G. Real-world clinical outcome and toxicity data and economic aspects in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy: the experience of the Hellenic Cooperative Oncology Group. ESMO Open. 2020 Aug;5(4):e000774. doi: 10.1136/esmoopen-2020-000774. PMID 32817060