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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

NCT01574170 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2026-04-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Florence MD DALENC · Institut Claudius Regaud

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-18
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01574170 on ClinicalTrials.gov