NCT03314870

Brief Summary

Breast cancer is the most frequent cancer in women. It is often treated with neoadjuvant chemotherapy, administered before surgical resection. Unfortunately, many patients do not respond to this treatment, or only respond partially. Clinicians therefore need predictive biomarkers of treatment response. Thanks to an innovative technique, called CATS, this study aims at identifying blood and tissue biomarkers which are predictive of response to chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

September 23, 2017

Last Update Submit

July 12, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • The number of molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition status and their immune status.

    an average of 2 years

Study Arms (2)

Retrospective study

OTHER

Tumoral tissue of 100 patients with breast cancer treated with neoadjuvant chemotherapy.

Genetic: Genetic signature

Prospective study

OTHER

Tumoral tissue and plasma of 120 patients with breast cancer treated with neoadjuvant chemotherapy.

Genetic: Genetic signature

Interventions

Genetic signatureGENETIC

To identify molecular signatures of EMT / immune status by using the random forest algorithm. The best signature will be measured by RT-qPCR and/or CATS-RNASeq technics.

Prospective studyRetrospective study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men with breast cancer
  • Treated with neoadjuvant chemotherapy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • François DUHOUX, MD, PhD

    francois.duhoux@uclouvain.be

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François DUHOUX, MD, PhD

CONTACT

00 32 2 764francois.duhoux@uclouvain.be

Nathalie BLONDEEL, MSc

CONTACT

00 32 2 764nathalie.blondeel@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2017

First Posted

October 19, 2017

Study Start

August 7, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

There is no IPD

Locations

BE(1)