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Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer

Development of a Response Signature to Neoadjuvant Chemotherapy for Breast

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03314870
Acronym
Breast-sign
Enrollment
220
Registered
2017-10-19
Start date
2017-08-07
Completion date
2019-12-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Detailed description

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. The objective of this study is to develop molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition (EMT) status and their immune status. As these two parameters are known to be responsible for incomplete responses to chemotherapy, investigators hypothesize that these signatures will be predictive of response to neoadjuvant chemotherapy. In a second step, researchers will evaluate the ability of these signatures to predict treatment response in breast cancer patients treated with neoadjuvant chemotherapy. The investigators will investigate two types of signatures: a tissue signature and a circulating signature. The former is based on the level of expression of several mRNA and miRNA assessed by CATS-RNASeq in the biopsy. The circulating signature will be based on the expression level of several miRNA by the same technique. Given that the expression level of tumoral miRNA is affected by the EMT and immunological status, and given that tumors secrete miRNA in the circulation, investigators expect the miRNA plasma content to reflect the EMT and immunological status of the tumor. The circulating signature will have the additional advantage of being independent of tumor heterogeneity.

Interventions

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.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
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

Countries

Belgium

Contacts

Primary ContactFrançois DUHOUX, MD, PhD
francois.duhoux@uclouvain.be00 32 2 764
Backup ContactNathalie BLONDEEL, MSc
nathalie.blondeel@uclouvain.be00 32 2 764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026