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

NCT ID: NCT01574170

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-18
• Study Completion Date: 2023-05-31

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

Conditions

Metastatic Breast Cancer Starting a Third Line Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence MD DALENC

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

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

Centre Hospitalier de Rodez

Rodez, , France

Centre Paul Strauss

Strasbourg, , France

Polyclinique de l'Ormeau

Tarbes, , France

CHU Rangueil

Toulouse, , France

Institut Claudius Regaud

Toulouse, , France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

11 SEIN 07

Identifier Type: -

Identifier Source: org_study_id