Survival Endpoints for Treatment Evaluation in Subjects Treated for Metastatic Breast Cancer: Contribution of Real-life Databases

Cancer Clinical Trial

Official title:

Survival Endpoints for Treatment Evaluation in Subjects Treated for Metastatic Breast Cancer: Contribution of Real-life Databases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03676257
• Other study ID #: IB-2017DATECAN-ESME
• Status: Active, not recruiting
• Start date: September 1, 2017
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Overall survival (OS) is considered the most reliable cancer endpoint and used by the Health Rregulatory authorities (HRA). OS presents multiple advantages in cancer randomized controlled trials (RCT): it is universally accepted as a measure of clinical benefit for the patient; it is objectively defined, both in terms of events and date of incidence; it is easily and precisely measured and thus reproducible; it can be exhaustively collected. As such, OS has been validated by HRAs. On the other hand, OS presents some limitations. Observing a benefit on OS may require a large number of patients and/or considerable time for patient follow-up. Costs for trials may be increased, and there might be delays in the introduction of possible beneficial treatments for patients. The development of alternative endpoints that could capture treatment benefit appropriately and be measurable earlier, is central for the evolution of clinical research in oncology. Real world data (RWD) are defined as other sources than clinical trials such as: electronic medical records, registries, insurance claims, pharmacy records, death certificates and other patient-generated data. This research is aimed at (i) describing the existing endpoints of survival in real-life setting, (ii) comparing the correlation at individual level with data to clinical trials for related to anti-HER2 targeted therapies and endocrine therapies in MBC. We will investigate the individual correlation between candidate surrogate endpoints and overall survival in a population-based record-computerized database centralizing data on about 20,000 patients from 2008 to 2017 in France. This work should lead to the estimation of various time-to event endpoints (e.g. OS, PFS, etc), in the real-life setting, for mBC patients. In addition, we will estimate their individual correlation with OS, which should help us highlight potential surrogate endpoints in this setting. We will focuss on three distinct population, accounting for a large population of mBS patients: : patients treated with anti-HER2 targeted agents, patients treated with endocrine therapies and elderly population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic breast cancer

Exclusion Criteria:

• Individual patient data unavailable

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer

Intervention

Other:
• Endocrine therapies
No intervention

Locations

Country	Name	City	State
France	Insitut Bergonié	Bordeaux

Sponsors (3)

Lead Sponsor	Collaborator
Institut Bergonié	Institut du Cancer de Montpellier - Val d'Aurelle, UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Time from diagnosis to death	2 years
Primary	Progression-free survival (PFS)	Time frim diagnosis to death or progression	2 years
Secondary	Relapse-free survival	As per Gourgou et al. Annals Oncol 2015	2 years
Secondary	Time to progression	As per Gourgou et al. Annals Oncol 2015	2 years