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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Construction of a prognostic score (non-drug intervention types) | Other | Record of clinical, histological and biological data and questionnaires data in patients starting a third line metastatic until progression |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence MD DALENC | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.M.C.O. Claude Bernard | Albi | 81000 | France | |||
| Institut de Cancérologie de l'Ouest Paul Papin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25460338 | Background | Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8. |
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| Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas | 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 | 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 | 11 years |
| Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0 | 11 years |
| Angers |
| 49933 |
| France |
| CHU Jean Minjoz | Besançon | 25030 | France |
| CHRU Brest | Brest | 26609 | France |
| Centre Hospitalier Jean Rougier | Cahors | 46005 | France |
| Centre Hospitalier Intercommunal de Castres-Mazamet | Castres | 81108 | France |
| Centre d'Oncologie et de Radiothérapie du Parc | Dijon | 21000 | France |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| Clinique La Croix du Sud | Quint-Fonsegrives | 31130 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Centre Hospitalier de Rodez | Rodez | 12000 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Polyclinique de l'Ormeau | Tarbes | 65000 | France |
| CHU Rangueil | Toulouse | 31000 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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