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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)

Primary Purpose

Metastatic Breast Cancer Starting a Third Line Chemotherapy

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Construction of a prognostic score (non-drug intervention types)
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Breast Cancer Starting a Third Line Chemotherapy focused on measuring Breast cancer,, Third line metastatic, Chemotherapy,, Overall survival,, Quality of life.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • C.M.C.O. Claude Bernard
  • Institut de Cancérologie de l'Ouest Paul Papin
  • CHU Jean Minjoz
  • CHRU Brest
  • Centre Hospitalier Jean Rougier
  • Centre Hospitalier Intercommunal de Castres-Mazamet
  • Centre d'Oncologie et de Radiothérapie du Parc
  • Centre Georges François Leclerc
  • Clinique La Croix du Sud
  • Centre Eugène Marquis
  • Centre Hospitalier de Rodez
  • Centre Paul Strauss
  • Polyclinique de l'Ormeau
  • CHU Rangueil
  • Institut Claudius Regaud
  • Institut de Cancérologie de Lorraine

Outcomes

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)

Secondary Outcome Measures

The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
Quality of life using the EORTC QLQ-C15-PAL Questionnaire
Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas
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
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
Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0

Full Information

First Posted
March 16, 2012
Last Updated
June 12, 2023
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT01574170
Brief 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
Acronym
METAL3
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2012 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer Starting a Third Line Chemotherapy
Keywords
Breast cancer,, Third line metastatic, Chemotherapy,, Overall survival,, Quality of life.

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Construction of a prognostic score (non-drug intervention types)
Intervention Description
Record of clinical, histological and biological data and questionnaires data in patients starting a third line metastatic until progression
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
Time Frame
11 years
Title
Quality of life using the EORTC QLQ-C15-PAL Questionnaire
Time Frame
11 years
Title
Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas
Time Frame
11 years
Title
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
Title
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
Title
Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0
Time Frame
11 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence MD DALENC
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
C.M.C.O. Claude Bernard
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
Institut de Cancérologie de l'Ouest Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHU Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
26609
Country
France
Facility Name
Centre Hospitalier Jean Rougier
City
Cahors
ZIP/Postal Code
46005
Country
France
Facility Name
Centre Hospitalier Intercommunal de Castres-Mazamet
City
Castres
ZIP/Postal Code
81108
Country
France
Facility Name
Centre d'Oncologie et de Radiothérapie du Parc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Clinique La Croix du Sud
City
Quint-fonsegrives
ZIP/Postal Code
31130
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Hospitalier de Rodez
City
Rodez
ZIP/Postal Code
12000
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Polyclinique de l'Ormeau
City
Tarbes
ZIP/Postal Code
65000
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54519
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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