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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)

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ClinicalTrials.gov Identifier: NCT01574170
Recruitment Status : Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 18, 2012
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


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


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression [ Time Frame: 7 years ]
  2. Quality of life using the EORTC QLQ-C15-PAL Questionnaire [ Time Frame: 7 years ]
  3. Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas [ Time Frame: 7 years ]
  4. 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 ]
  5. 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 ]
  6. Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0 [ Time Frame: 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574170


Locations
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France
C.M.C.O. Claude Bernard
Albi, France, 81000
Institut de Cancérologie de l'Ouest Paul Papin
Angers, France, 49933
CHU Jean Minjoz
Besançon, France, 25030
CHRU Brest
Brest, France, 26609
Centre Hospitalier Jean Rougier
Cahors, France, 46005
Centre Hospitalier Intercommunal de Castres-Mazamet
Castres, France, 81108
Centre d'Oncologie et de Radiothérapie du Parc
Dijon, France, 21000
Centre Georges François Leclerc
Dijon, France, 21079
Centre Eugène Marquis
Rennes, France, 35042
Centre Hospitalier de Rodez
Rodez, France, 12000
Centre Paul Strauss
Strasbourg, France, 67065
Polyclinique de l'Ormeau
Tarbes, France, 65000
CHU Rangueil
Toulouse, France, 31000
Institut Claudius Regaud
Toulouse, France, 31052
Clinique La Croix du Sud
Toulouse, France, 31400
Institut de Cancérologie de Lorraine
Vandoeuvre Les Nancy, France, 54519
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
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Principal Investigator: Florence MD DALENC Institut Claudius Regaud
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01574170    
Other Study ID Numbers: 11 SEIN 07
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Keywords provided by Institut Claudius Regaud:
Breast cancer,
Third line metastatic
Chemotherapy,
Overall survival,
Quality of life.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases