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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CGFL

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women more than 18 years old
breast cancer recently diagnosis (no prior treatment), histologically proven
stade II or III in the "International union against cancer"(UICC) classification
non metastatic patient
Eastern Cooperative Oncology Group (ECOG) 0 or 1
Negativity of estrogen and progesterone receptor of the tumor (<10%)
Absence of overexpression of HER2 according to the classification Immunohistochemistry (IHC) - score 0 or 1+
Patient having read the information note
written, dated and signed Informed consent

Exclusion criteria

Unresectable breast cancer, bilateral, inflammatory (T4d) or metastatic.
Unbalanced diabetes during PET scans (glucose more or equal to 9 mmol)
Small breast cancer indication with first-conserving surgery
Treated breast cancer history
Pregnancy or breastfeeding
Refusal of the patient for trial participation
Private Person of liberty under supervision or under curators
Inability to submit to medical follow-up testing for social or psychological reasons
No affiliation to a social security scheme or medical state aid or the universal medical coverage
Known allergy or hypersensitivity to 18F-fluorodeoxyglucose
Patients with known renal impairment (creatinine clearance <60 ml / min / 1.73m2) or a known hepatic failure
Patients with a strict regime without salt (sodium levels may be higher than 1 mmol in a dose of 18 FDG).

Treatment and study plan

PET with FDG

Other

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

Tumor exome analysis

Other

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.

Primary outcomes

Variation of mutational profile

Time frame: 15 days

Variation of the mutational profile of the tumor will be assess by exome analysis

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Acronym: TRANSTEP

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Aug 1, 2016
Registry last updated: Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed