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Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer (Breast-sign)

C

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown

Conditions

Breast Cancer

Treatments

Genetic: Genetic signature

Study type

Interventional

Funder types

Other

Identifiers

NCT03314870
2017/25JUL/376

Details and patient eligibility

About

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.

Full 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.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • None

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 2 patient groups

Retrospective study
Other group
Description:
Tumoral tissue of 100 patients with breast cancer treated with neoadjuvant chemotherapy.
Treatment:
Genetic: Genetic signature
Prospective study
Other group
Description:
Tumoral tissue and plasma of 120 patients with breast cancer treated with neoadjuvant chemotherapy.
Treatment:
Genetic: Genetic signature

Trial contacts and locations

1

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Central trial contact

François DUHOUX, MD, PhD; Nathalie BLONDEEL, MSc

Data sourced from clinicaltrials.gov

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