Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival (METAL3)

April 14, 2026 updated by: Institut Claudius Regaud

This is a biomedical study of interventional type. The trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up.

This prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer.

The main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line.

This score will then be validated on the 2nd cohort.

There will be no interruption of inclusions between first and second cohort of patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi, France, 81000
        • C.M.C.O. Claude Bernard
      • Angers, France, 49933
        • Institut de Cancerologie de l'Ouest Paul Papin
      • Besançon, France, 25030
        • Chu Jean Minjoz
      • Brest, France, 26609
        • CHRU Brest
      • Cahors, France, 46005
        • Centre Hospitalier Jean Rougier
      • Castres, France, 81108
        • Centre Hospitalier Intercommunal de Castres-Mazamet
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Dijon, France, 21000
        • Centre d'Oncologie et de Radiothérapie du Parc
      • Quint-Fonsegrives, France, 31130
        • Clinique La Croix Du Sud
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rodez, France, 12000
        • Centre Hospitalier de Rodez
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Tarbes, France, 65000
        • Polyclinique de l'Ormeau
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Toulouse, France, 31000
        • CHU Rangueil
      • Vandœuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women of more than 18 years old
  2. WHO 0-4
  3. Metastatic breast cancer
  4. Progression after two lines of chemotherapy with treatment decision by investigator to start a third-line chemotherapy
  5. Evaluable disease
  6. Histology: breast carcinoma whatever the histological type, grade, hormone receptor expression and HER-2
  7. Patient able to complete the EORTC PAL 15 Questionnaire
  8. Patient member in a national insurance scheme
  9. Informed consent obtained and signed by the patient

Exclusion Criteria:

  1. History of other (s) cancer (s) potentially metastatic (s)
  2. Woman participating in a third line chemotherapy clinical trial
  3. Pregnant women or nursing mothers can not participate in the study
  4. Patient under legal guardianship
  5. Patient unable to undergo medical test for various reasons including social or psychological reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
Time Frame: 11 years
11 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
Time Frame: 11 years
11 years
Quality of life using the EORTC QLQ-C15-PAL Questionnaire
Time Frame: 11 years
11 years
Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas
Time Frame: 11 years
11 years
Oncologists satisfaction regarding the management and communication with the patient will be studied at baseline and at the time or progression using the Likert ordinal scale
Time Frame: 7 years
7 years
Regret or not of the patient to have followed a 3rd line of chemotherapy will be recorded at the end of the treatment using the "Decision regret scale" Questionnaire, established by A. O'Connor
Time Frame: 11 years
11 years
Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0
Time Frame: 11 years
11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Investigators

  • Principal Investigator: Florence MD DALENC, Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2012

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimated)

April 10, 2012

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11 SEIN 07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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