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NCT06619704 · ClinicalTrials.gov registry record
Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy
A clinical trial of Metastatic Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 194
- Enrollment target
- 1
- Study location
NCT06619704: Completed study of Metastatic Breast Cancer, sponsored by Novartis Pharmaceuticals.
NCT06619704 is a study of Metastatic Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 194 participants, roughly in line with the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06619704, a study of Metastatic Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 194 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Treatment combinations included ribociclib plus letrozole and ribociclib plus fulvestrant. ORR was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1.
Conditions Studied
Study Locations (1)
New Jersey
- Novartis Pharmaceuticals - East Hanover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2023-09-27 |
What the finished NCT06619704 record still lists
NCT06619704 is an observational study that tracks outcomes without assigning an intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT06619704 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06619704 about?
NCT06619704 is a clinical study titled "Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy". 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...
What is the current status of trial NCT06619704?
This trial is currently completed. The enrollment target is 194 participants. The study started on 2022-08-10. Estimated completion is 2023-09-27.
What conditions does trial NCT06619704 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
Who is sponsoring clinical trial NCT06619704?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06619704 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06619704's enrollment target sits among peer trials
194 32nd of 139 higher than 107 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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