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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Institut Claudius Regaud
Sponsor:
Information provided by (Responsible Party):
Muriel POUBLANC, Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01574170
First received: March 16, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer Starting a Third Line Chemotherapy
Other: Construction of a prognostic score (non-drug intervention types)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • 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: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Quality of life using the EORTC QLQ-C15-PAL Questionnaire [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
  • Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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: 7 years ] [ Designated as safety issue: No ]
  • Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0 [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 270
Study Start Date: May 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Construction of a prognostic score (non-drug intervention types)
    Record of clinical, histological and biological data and questionnaires data in patients starting a third line metastatic until progression
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574170

Contacts
Contact: Florence Md DALENC +33 5.61.42.41.28 Dalenc.florence@claudiusregaud.fr

Locations
France
Institut de Cancérologie de l'Ouest Paul Papin Recruiting
Angers, France, 49933
Contact: Patrick SOULIE, PhD    + 33 2 41 35 27 34    p.soulié@unimedia.fr   
Principal Investigator: Patrick SOULIE, PhD         
Sub-Investigator: Sophie ABADIE LACOURTOISIE, PhD         
Sub-Investigator: Rémy DELVA, PhD         
Sub-Investigator: Olivier Joseph CAPITAIN, PhD         
Sub-Investigator: Philippe MAILLART, PhD         
CHRU Brest Recruiting
Brest, France, 26609
Contact: Hélène SIMON, PhD    +33 2 98 22 33 95    helene.simon@chu-brest.fr   
Principal Investigator: Hélène SIMON, PhD         
Sub-Investigator: Brigitte LUCAS, PhD         
Centre Georges François Leclerc Recruiting
Dijon, France, 21079
Contact: Isabelle DESMOULINS, PhD    +33 3 45 34 80 51    idesmoulins@cgfl.fr   
Principal Investigator: Isabelle DESMOULINS, PhD         
Sub-Investigator: Séverine GUIU, PhD         
Sub-Investigator: Bruno COUDERT, PhD         
Sub-Investigator: Françoise MAYER, PhD         
Institut Curie Not yet recruiting
Paris, France, 75005
Contact: Jean-Yves PIERGA, PhD    +33 1 44 32 42 76    Jean-yves.pierga@curie.net   
Principal Investigator: Jean-Yves PIERGA, PhD         
Centre Eugène Marquis Not yet recruiting
Rennes, France, 35042
Contact: Pierre KERBRAT, PhD    +33 2 99 25 32 80    kerbrat@rennes.fnclcc.fr   
Principal Investigator: Pierre KERBRAT, PhD         
Sub-Investigator: Claudia LEFEUVRE, PhD         
Sub-Investigator: Elodie VAULEON, PhD         
Sub-Investigator: Daniel GEDOUIN, PhD         
Sub-Investigator: Julien EDELINE, PhD         
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Florence DALENC, PhD    +33 5.61.42.41.28    Dalenc.florence@claudiusregaud.fr   
Sub-Investigator: Laurence GLADIEFF, PhD         
Sub-Investigator: Jean-Louis LACAZE, PhD         
Sub-Investigator: Henri ROCHE, Pr         
Principal Investigator: Florence DALENC, PhD         
CHU Rangueil Recruiting
Toulouse, France, 31000
Contact: Marion DESLANDRES, PhD    + 33 5 61 32 36 16    deslandres.m@chu-toulouse.fr   
Principal Investigator: Marion DESLANDRES, PhD         
Sub-Investigator: Pascale RIVERA, PhD         
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Florence MD DALENC Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Muriel POUBLANC, Principal investigator, Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01574170     History of Changes
Other Study ID Numbers: 11 SEIN 07
Study First Received: March 16, 2012
Last Updated: November 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Breast cancer,
Third line metastatic
Chemotherapy,
Overall survival,
Quality of life.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014