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)

• ClinicalTrials.gov Identifier: NCT01574170
• Recruitment Status: Active, not recruiting
• First Posted: April 10, 2012
• Last Update Posted: July 7, 2020
• Sponsor: Institut Claudius Regaud
• Information provided by (Responsible Party): Institut Claudius Regaud

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

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

Study Design

• 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 2021
• Estimated Study Completion Date: June 2021

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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 Saint-Jean du Languedoc

Toulouse, France, 31400

Institut de Cancérologie de Lorraine

Vandoeuvre Les Nancy, France, 54519

Sponsors and Collaborators

Institut Claudius Regaud

Investigators

• Principal Investigator: Florence MD DALENC; Institut Claudius Regaud

More Information

• Responsible Party: Institut Claudius Regaud
• ClinicalTrials.gov Identifier: NCT01574170
• Other Study ID Numbers: 11 SEIN 07
• First Posted: April 10, 2012
• Last Update Posted: July 7, 2020
• Last Verified: July 2020

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