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

Institut Claudius Regaud267 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

267

Conditions

Metastatic Breast Cancer Starting a Third Line Chemotherapy

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

C.M.C.O. Claude Bernard

Albi, France

Institut de Cancérologie de l'Ouest Paul Papin

Angers, France

CHU Jean Minjoz

Besançon, France

CHRU Brest

Brest, France

Centre Hospitalier Jean Rougier

Cahors, France

Centre Hospitalier Intercommunal de Castres-Mazamet

Castres, France

Centre d'Oncologie et de Radiothérapie du Parc

Dijon, France

Centre Georges François Leclerc

Dijon, France

Clinique La Croix du Sud

Quint-Fonsegrives, France

Centre Eugène Marquis

Rennes, France

...and 6 more locations

Outcomes

Primary Outcomes

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 Outcomes

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

Time frame: 11 years

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

Time frame: 11 years

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

Time frame: 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

Time frame: 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

Time frame: 11 years

Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0

Time frame: 11 years