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

NCT01574170 | Completed Phase 4

• 1 other identifier: 11 SEIN 07
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Metastatic Breast Cancer Starting a Third Line Chemotherapy

Keywords

Breast cancer,; Third line metastatic; Chemotherapy,; Overall survival,; Quality of life.

Outcome Measures

Primary Outcomes (1)

• Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)

  11 years

Secondary Outcomes (6)

• The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression

  11 years

• Quality of life using the EORTC QLQ-C15-PAL Questionnaire

  11 years

• Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas

  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

  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

  11 years

Interventions

Construction of a prognostic score (non-drug intervention types) OTHER

Record of clinical, histological and biological data and questionnaires data in patients starting a third line metastatic until progression

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (16)

C.M.C.O. Claude Bernard

Albi, 81000, France

Location

Institut de Cancérologie de l'Ouest Paul Papin

Angers, 49933, France

Location

CHU Jean Minjoz

Besançon, 25030, France

Location

CHRU Brest

Brest, 26609, France

Location

Centre Hospitalier Jean Rougier

Cahors, 46005, France

Location

Centre Hospitalier Intercommunal de Castres-Mazamet

Castres, 81108, France

Location

Centre d'Oncologie et de Radiothérapie du Parc

Dijon, 21000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Clinique La Croix du Sud

Quint-Fonsegrives, 31130, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Hospitalier de Rodez

Rodez, 12000, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Polyclinique de l'Ormeau

Tarbes, 65000, France

Location

CHU Rangueil

Toulouse, 31000, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

• Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.

  PMID: 25460338 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Florence MD DALENC

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: April 10, 2012
• Study Start: June 18, 2012
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

FR (16)