NCT01574170

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Breast Cancer Starting a Third Line Chemotherapy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-06-18
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2012-04-10
• Last updated: 2026-04-17

Locations

16 sites across 1 country: France