Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer Starting a Third Line Chemotherapy | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Construction of a prognostic score (non-drug intervention types) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
- timeFrame
- 11 years
Secondary outcomes (6)
- measure
- The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
- timeFrame
- 11 years
- measure
- Quality of life using the EORTC QLQ-C15-PAL Questionnaire
- timeFrame
- 11 years
- measure
- Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas
- timeFrame
- 11 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDFilleron 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. PMID 25460338