Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Chemotherapy in Patients With Mammary Gland Cancer (TREN)

Centre Georges Francois Leclerc

Status: Active, not recruiting

Conditions: FDG PET

Treatments: Device: FDG PET

Study type: Interventional

Funder types: Other

Identifiers

NCT02386709

2014-A000357-40

Details and patient eligibility

About

Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate of pCR is about 20%, although there are important variations according to tumor subtype and the type of treatment. The objective of the new therapeutic strategies is to increase this response rate.

The purpose of this study is to investigate the possibility of early evaluation of neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.

Enrollment: 275 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient having been informed of the study
• patient affiliated to a social health insurance
• ≥ 18 years
• patient presenting a breast cancer histologically confirmed
• indication of neoadjuvant chemotherapy treatment (classification UICC: II or III)
• patient agrees with exploitation of his clinical, biological and image data

Exclusion criteria

• distant metastasis
• contraindications to chemotherapy
• contraindications to surgery
• refusal
• serious illness not balanced, subjacent infection
• pregnancy or breast feeding
• diabetes not controlled (glycemia> 8 mmol/L)
• psychiatric disease
• patient under supervision, trusteeship or safeguard of justice

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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275 participants in 1 patient group

Experimental Arm

Experimental group

Description:

1. Diagnostic 2. PET1 : before the neoadjuvant treatment 3. start neoadjuvant treatment 4. PET2: two weeks after the start of the first course of chemotherapy 5. surgery

Treatment:

Device: FDG PET