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NCT06619704
Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy
trial in Metastatic Breast Cancer in 194 participants. Completed in 27 September 2023.
27 September 2023
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 194 |
| Start date | 10 August 2022 |
| Primary completion | 27 September 2023 |
| Estimated completion | 27 September 2023 |
| Sites | 1 location across United States |
Conditions studied
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
EILEEN was a non-interventional/observational, retrospective, multi-center, real life cohort study conducted in 14 private and academic oncology clinics in Turkey. Group I cohort of the study was based on secondary use of data of postmenopausal hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) patients treated with ribociclib in combination with letrozole (LET) or fulvestrant (FUL) after June 2020. Group II cohort of the study was a parallel, comprehensive chart review for detecting all postmenopausal HR+, HER2- MBC patients who were eligible for cyclin-dependent kinase inhibitors (CDKis) but received chemotherapy. The study used secondary data which was retrieved from electronic or paper medical records or clinical databases available at the sites. Regular follow up with close monitorization was used for the effective management of patients with breast cancer. Data sources included information about diagnosis, treatment and monitorization of patients at an individual level. The study used medical patient records at hospitals e.g. hospital discharge files, primary clinical records and electronic medical records.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06619704
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06619704 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 4 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06619704.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing