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Clinico-biological Data Collection Study of Metastatic Breast Cancer

NCT03958136 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2025-08-17

No results posted yet for this study

Summary

RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.

PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and bio-pathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

Conditions

Interventions

PROCEDURE

Metastasis biopsy

Metastasis biopsy will be performed for multi-omic analysis

BIOLOGICAL

Biomarkers blood, urine and microbiota samples

Biomarkers blood, urine and microbiota samples for multi-omic analysis

BEHAVIORAL

Patient Reported Outcome (PRO)

Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.

Sponsors & Collaborators

  • European Regional Development Fund

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Mario CAMPONE, MD, PhD · Institut de Cancerologie de l'Ouest

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-24
Primary Completion
2035-12-24
Completion
2036-12-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

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 NCT03958136 on ClinicalTrials.gov