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
- Conditions
- Metastatic Breast Cancer Starting a Third Line Chemotherapy
- Registration Number
- NCT01574170
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 267
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data) 11 years
- Secondary Outcome Measures
Name Time Method 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 7 years Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas 11 years The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression 11 years Quality of life using the EORTC QLQ-C15-PAL Questionnaire 11 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 11 years Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0 11 years
Trial Locations
- Locations (16)
Institut de Cancérologie de l'Ouest Paul Papin
🇫🇷Angers, France
C.M.C.O. Claude Bernard
🇫🇷Albi, France
CHU Jean Minjoz
🇫🇷Besançon, France
CHRU Brest
🇫🇷Brest, France
Centre Hospitalier Jean Rougier
🇫🇷Cahors, France
Clinique La Croix du Sud
🇫🇷Quint-fonsegrives, France
Centre d'Oncologie et de Radiothérapie du Parc
🇫🇷Dijon, France
Centre Hospitalier Intercommunal de Castres-Mazamet
🇫🇷Castres, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Centre Hospitalier de Rodez
🇫🇷Rodez, France
Centre Eugène Marquis
🇫🇷Rennes, France
Centre Paul Strauss
🇫🇷Strasbourg, France
CHU Rangueil
🇫🇷Toulouse, France
Polyclinique de l'Ormeau
🇫🇷Tarbes, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre Les Nancy, France