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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


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer Starting a Third Line Chemotherapy

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)

Outcome Time Frame:

7 years

Safety Issue:

No

Principal Investigator

Florence MD DALENC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

11 SEIN 07

NCT ID:

NCT01574170

Start Date:

May 2012

Completion Date:

April 2017

Related Keywords:

  • Metastatic Breast Cancer Starting a Third Line Chemotherapy
  • Breast cancer,
  • Third line metastatic
  • Chemotherapy,
  • Overall survival,
  • Quality of life.
  • Breast Neoplasms

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