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Metastatic Breast CancerNCT03676257

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

An observational study of Metastatic Breast Cancer, run by Institut Bergonié at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Chemotherapy (exclusive), Endocrine therapy (exclusive) and Combination of endocrine therapy and chemotherapy
How many people
20,033 participants
Where
1 siteFrance
Study dates
1 Jan 2008to 1 Dec 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Data source : We extracted data from the ESME mBC database (NCT03275311) which gathers deidentified data from consecutive patients managed in 18 French Comprehensive Cancer Centers. Adult women diagnosed with mBC between 2008 and 2017 were included. The Epidemio-Strategy and Medical Economic (ESME) Research Program is a French academic initiative supporting the centralization of structured and non- structured data documented in the electronic health records (EHR) (clinical notes, pathology reports and radiology reports) of patients treated for malignant conditions in a unique secured web-based data platform available for researchers. The ESME mBC data platform is an EHR-derived database that gathers exhaustive data on consecutive patients who initiated a L1 treatment for mBC between 01 January 2008 and 31 December 2017 in one of 18 French Comprehensive Cancer Centers.

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).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Insitut Bergonié

    Bordeaux, 33076

Other trials in France

About this study

Official title: Survival Endpoints for Treatment Evaluation in Subjects 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.

Read more

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.

Being tested
Chemotherapy (exclusive), Endocrine therapy (exclusive), Combination of endocrine therapy and chemotherapy, Chemotherapy and targeted treatment, Combination of endocrine therapy and targeted treatment
Keywords
Metastatic breast cancer, Real world data, Surrogate
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 chemotherapyDrug

    Any combination of endocrine therapy and chemotherapy

  • Chemotherapy and targeted treatmentDrug

    Any combination of chemotherapy and targeted treatment(s)

  • Combination of endocrine therapy and targeted treatmentDrug

    Any combination of endocrine therapy and targeted treatment

  • Combination of chemotherapy, endocrine therapy and targeted treatmentDrug

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

Study groups in NCT03676257
Study groupRoleWhat they receive
Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC)Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC)
Receives: Drug: Chemotherapy (exclusive); Drug: Endocrine therapy (exclusive); Drug: Combination of endocrine therapy and chemotherapy; Drug: Chemotherapy and targeted treatment; Drug: Combination of endocrine therapy and targeted treatment; Drug: Combination of chemotherapy, endocrine therapy and targeted treatment
Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC)Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC)
Receives: Drug: Chemotherapy (exclusive); Drug: Chemotherapy and targeted treatment
Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC)Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC)
Receives: Drug: Chemotherapy (exclusive); Drug: Endocrine therapy (exclusive); Drug: Combination of endocrine therapy and chemotherapy; Drug: Chemotherapy and targeted treatment; Drug: Combination of endocrine therapy and targeted treatment; Drug: Combination of chemotherapy, endocrine therapy and targeted treatment
Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC)Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC)
Receives: Drug: Chemotherapy (exclusive); Drug: Chemotherapy and targeted treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 10 years

Secondary outcomes (2)

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

    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.

    Measured: 10 years

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

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

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2018
  2. Study start1 Jan 2008
  3. Primary completion1 Dec 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
20,033 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03676257
Sponsor's protocol ID
IB-2017DATECAN-ESME
Status last verified
Nov 2025
First submitted
17 Sep 2018
Last updated
10 Dec 2025
Data monitoring committee
No
Individual data sharing
No: Availability of data and materials : The data that support the findings of this study are available from UNICANCER but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of UNICANCER.

Publications

  • Courtinard C, Gourgou S, Jacot W, Carton M, Guerin O, Vacher L, Bertaut A, Le Deley MC, Perol D, Marino P, Levy C, Uwer L, Perrocheau G, Schiappa R, Bachelot F, Parent D, Breton M, Petit T, Filleron T, Loeb A, Mathoulin-Pelissier S, Robain M, Delaloge S, Bellera C. Association between progression-free survival and overall survival in women receiving first-line treatment for metastatic breast cancer: evidence from the ESME real-world database. BMC Med. 2023 Mar 8;21(1):87. doi: 10.1186/s12916-023-02754-5.

    PubMed 36882736

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer, run by Institut Bergonié at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) for Commonly Prescribed First-line Treatment Strategies (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03676257, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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