Dissecting the Pathways of Therapy Resistance in Early Breast Cancer

Terminated

• Conditions: Breast Cancer
• Interventions: Procedure: collection of the biopsy, blood samples

• Registration Number: NCT04995575
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

Within the 1st step MINDACT patients who have already relapsed will be asked to participate. For these patients a biopsy of the metastasis should have been taken. A molecular analysis of the stored primary tumor sample and of the metastatic sample, using new technologies, will be performed, and the characteristics of both samples will be compared.

Within the 2nd step a prospective collection of the metastasis samples will be implemented and analysis of biological material from relapsing MINDACT patients is foreseen.

This process will provide insights on the biology of breast cancer and allow us to better understand mechanisms of resistance to therapies, contributing to overcoming this important problem.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-07
• Study Start: 2020-07-08
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-09
• Primary Completion: 2022-05-09
• Study Completion: 2023-10-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all MINDACT patients who relapse	collection of the biopsy, blood samples	-

Primary Outcome Measures

Name	Time	Method
Disease progression	2 years after FPI	Characterization of disease progression using molecular characterization of tumour and germline molecular markers in tissue and blood.
Number of enrolled patients per year with adequate clinicopathologically annotated biological material and clinical data.	2 years after FPI	Collection of tissue from the first site of relapse or new primary breast cancer, and blood samples for patients still alive that have relapsed (retrospective collection) or will relapse (prospective collection)
Treatment resistance	2 years after FPI	Treatment resistance studies aiming to verify if a given mechanism is responsible for the relapse after exposure to anticancer agents will be performed using molecular characterization of tumour and germline molecular markers in tissue and blood..

Trial Locations

Locations (5)

CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur; 🇧🇪 Namur, Belgium

Onze Lieve Vrouw Ziekenhuis; 🇧🇪 Aalst, Belgium

Hopital De Jolimont; 🇧🇪 Haine-Saint-Paul, Belgium

Institut Jules Bordet-Hopital Universitaire ULB; 🇧🇪 Brussels, Belgium

Ziekenhuisgroep Twente - Twenteborg Ziekenhuis (3); 🇳🇱 Almelo, Netherlands