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

Breast Neoplasms Clinical Trial

— TRANSTEP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850302
• Other study ID #: TRANSTEP
• Status: Completed
• Phase: N/A
• Start date: November 8, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: August 2018
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 31, 2017
• Est. primary completion date: November 8, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CGFL	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of mutational profile	Variation of the mutational profile of the tumor will be assess by exome analysis	15 days