Metastatic Breast Cancer Starting a Third Line Chemotherapy
Conditions
Keywords
Breast cancer,, Third line metastatic, Chemotherapy,, Overall survival,, Quality of life.
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
Interventions
OTHERConstruction 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
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFlorence MD DALENC
Institut Claudius Regaud
Outcome results
None listed