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Survival Endpoints in Women Treated for Metastatic Breast Cancer: Contribution of Real-life Databases

NCT03676257 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20033

Last updated 2025-12-10

Study results available
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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.

Conditions

Interventions

DRUG

Chemotherapy (exclusive)

Administration of any chemotherapeutic agent(s)

DRUG

Endocrine therapy (exclusive)

Administration of any type of endocrine therapy

DRUG

Combination of endocrine therapy and chemotherapy

Any combination of endocrine therapy and chemotherapy

DRUG

Chemotherapy and targeted treatment

Any combination of chemotherapy and targeted treatment(s)

DRUG

Combination of endocrine therapy and targeted treatment

Any combination of endocrine therapy and targeted treatment

DRUG

Combination of chemotherapy, endocrine therapy and targeted treatment

Any combination of chemotherapy, endocrine therapy and targeted treatment(s)

Sponsors & Collaborators

  • UNICANCER

    collaborator OTHER

  • Institut du Cancer de Montpellier - Val d'Aurelle

    collaborator OTHER

  • Institut Bergonié

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03676257 on ClinicalTrials.gov