Clinical trial NCT01574170: 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
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Breast Cancer Starting a Third Line Chemotherapy
Keywords: Breast cancer,
Third line metastatic
Chemotherapy,
Overall survival,
Quality of life.
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility 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.

Primary outcomes:
measure: Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
timeFrame: 11 years
Secondary outcomes:
measure: The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
timeFrame: 11 years
measure: Quality of life using the EORTC QLQ-C15-PAL Questionnaire
timeFrame: 11 years
measure: Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas
timeFrame: 11 years
measure: 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
timeFrame: 7 years
measure: 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
timeFrame: 11 years
measure: Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0
timeFrame: 11 years
Other outcomes:
Locations:
city: Albi
country: France
facility: C.M.C.O. Claude Bernard
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest Paul Papin
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Brest
country: France
facility: CHRU Brest
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougier
city: Castres
country: France
facility: Centre Hospitalier Intercommunal de Castres-Mazamet
city: Dijon
country: France
facility: Centre d'Oncologie et de Radiothérapie du Parc
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Quint-fonsegrives
country: France
facility: Clinique La Croix du Sud
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rodez
country: France
facility: Centre Hospitalier de Rodez
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
city: Toulouse
country: France
facility: CHU Rangueil
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre Les Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut Claudius Regaud
name: Florence MD DALENC
role: PRINCIPAL_INVESTIGATOR
References: