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 (METAL3)
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ClinicalTrials.gov Identifier: NCT01574170 |
Recruitment Status :
Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : July 7, 2020
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer Starting a Third Line Chemotherapy | Other: Construction of a prognostic score (non-drug intervention types) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 267 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | June 18, 2012 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2021 |

- Other: 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
- 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: 7 years ]
- The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression [ Time Frame: 7 years ]
- Quality of life using the EORTC QLQ-C15-PAL Questionnaire [ Time Frame: 7 years ]
- Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas [ Time Frame: 7 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: 7 years ]
- Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0 [ Time Frame: 7 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574170
France | |
C.M.C.O. Claude Bernard | |
Albi, France, 81000 | |
Institut de Cancérologie de l'Ouest Paul Papin | |
Angers, France, 49933 | |
CHU Jean Minjoz | |
Besançon, France, 25030 | |
CHRU Brest | |
Brest, France, 26609 | |
Centre Hospitalier Jean Rougier | |
Cahors, France, 46005 | |
Centre Hospitalier Intercommunal de Castres-Mazamet | |
Castres, France, 81108 | |
Centre d'Oncologie et de Radiothérapie du Parc | |
Dijon, France, 21000 | |
Centre Georges François Leclerc | |
Dijon, France, 21079 | |
Centre Eugène Marquis | |
Rennes, France, 35042 | |
Centre Hospitalier de Rodez | |
Rodez, France, 12000 | |
Centre Paul Strauss | |
Strasbourg, France, 67065 | |
Polyclinique de l'Ormeau | |
Tarbes, France, 65000 | |
CHU Rangueil | |
Toulouse, France, 31000 | |
Institut Claudius Regaud | |
Toulouse, France, 31052 | |
Clinique Saint-Jean du Languedoc | |
Toulouse, France, 31400 | |
Institut de Cancérologie de Lorraine | |
Vandoeuvre Les Nancy, France, 54519 |
Principal Investigator: | Florence MD DALENC | Institut Claudius Regaud |
Responsible Party: | Institut Claudius Regaud |
ClinicalTrials.gov Identifier: | NCT01574170 |
Other Study ID Numbers: |
11 SEIN 07 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | July 7, 2020 |
Last Verified: | July 2020 |
Breast cancer, Third line metastatic Chemotherapy, Overall survival, Quality of life. |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |