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Triple Negative Breast Cancer: Identification Pilot Study of Predictive Transcriptome Profiles of Early Tumor Drug Resistance Observed in 18F-Fluorodeoxyglucose (FDG) PET

NCT02850302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-08-09

No results posted yet for this study

Summary

Breast cancer is a major public health problem. In France, it is the leading cause of cancer death in women. According to the National Cancer Institute (INCA), approximately 49,000 new cases were diagnosed in 2012 in France.

It is an heterogeneous disease, comprising a plurality of entities whose clinical behavior, biological and prognosis differ. Amongst these entities, the breast cancer triple negative (TN) is defined by the absence of expression of estrogen receptor and progesterone and the absence of overexpression of HER2 oncoprotein. It represents about 15% of breast cancers and occurs more frequently in young women. This is a very proliferative tumor phenotype with metastatic potential. Because of its genomic heterogeneity and lack of recurrent identified molecular target, no targeted therapy has today shown benefit in terms of survival compared to conventional cytotoxic chemotherapy, which partly explains the very poor prognosis of this tumor phenotype. The positron emission tomography (PET) with 18Fluoro-deoxy-glucose (FDG) is a molecular imaging test that can identify from the first or second neoadjuvant chemotherapy treatment non-responder patients to treatment with low probability of pathologic complete response (pCR) after neoadjuvant chemotherapy. For this two FDG-PET examinations should be performed; a) a pretreatment PET b) a control PET after one or two treatments. The objective of this pilot, single-center, prospective study is a preliminary identification of recurrent genomic alterations among triple-negative tumors with early chemoresistance, identified by PET in the first cycle of neoadjuvant therapy.

Conditions

  • Breast Neoplasms

Interventions

OTHER

PET with FDG

A PET with FDG will be performed before the treatment is started and after 6 cycles of chemotherapy.

OTHER

Tumor exome analysis

A biopsy of the tumor will be performed before the treatment is started and after 6 cycles of chemotherapy. Tumor exome analysis will be performed before treatment is started and after 6 cycles of chemotherapy.

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Principal Investigators

  • Pierre Fumoleau, Pr · Centre Georges François Leclerc

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-08
Primary Completion
2016-11-08
Completion
2017-10-31

Countries

  • France

Study Locations

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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 NCT02850302 on ClinicalTrials.gov