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NCT Number: NCT03676257

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

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Insitut Bergonié

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

ELIGIBILITY

  • female patients older than 18 years
  • diagnosis of metastatic breast cancer (de novo disease or first metastatic recurrence) between January 1, 2008, and December 31, 2017
  • received a fist-line systemic treatment such as chemotherapy, endocrine therapy or targeted therapy, whatever the sequence (monotherapy or combination of therapies using distinct mechanisms of actions, i.e., polytherapy).

Treatment and study plan

Chemotherapy (exclusive)

Drug

Administration of any chemotherapeutic agent(s)

Endocrine therapy (exclusive)

Drug

Administration of any type of endocrine therapy

Combination of endocrine therapy and chemotherapy

Drug

Any combination of endocrine therapy and chemotherapy

Chemotherapy and targeted treatment

Drug

Any combination of chemotherapy and targeted treatment(s)

Combination of endocrine therapy and targeted treatment

Drug

Any combination of endocrine therapy and targeted treatment

Combination of chemotherapy, endocrine therapy and targeted treatment

Drug

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

Primary outcomes

  1. Overall Survival (OS) for Commonly Prescribed First-line Treatment Strategies

    Time frame: 10 years

    OS was defined as the time from diagnosis of mBC to the date of death from any cause.

Secondary outcomes

  1. Real-world Progression-free Survival (rwPFS) for Commonly Prescribed First-line Treatment Strategies

    Time frame: 10 years

    rwPFS was defined as the delay between time from initial diagnosis of mBC to the date of disease progression (regional recurrence, progression, appearance/occurrence of metastases and distant recurrence) or death (any cause), whichever came first.

    Disease progression was assessed by the treating physician based on observed clinical events, as per routine practice (regional recurrence, progression, appearance/occurrence of metastases and distant recurrence). These events were recorded in the patient medical record. As this study relates to real-world data, no specific procedure was imposed to assess these events.

  2. Association Between Overall Survival and Real-world Progression-free Survival for Commonly Prescribed First-line Treatment Strategies

    Time frame: 10 years

    Individual-level association between rwPFS and OS estimated using a Spearman rank correlation coefficient.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle
  • UNICANCER

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2018
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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