PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The two main objectives of this prospective study are: to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1), to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2). The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer . This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a de-identified file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.

Official Title
-----------------
Role of Fluorodeoxyglucose (FDG) PET-CT in the Initial Staging of Breast Cancer (ASAINT 1) and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT 2)

Conditions
-----------------
Breast Cancer, Positron-Emission Tomography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Histologically confirmed breast cancer Stage II and III breast cancer Neo-adjuvant chemotherapy Baseline PET-CT-scan (ASAINT 1 and 2) PET-CT-scans after second cycle of neo-adjuvant chemotherapy (ASAINT 2) Tumor biopsy for diagnosis and biological analysis with hormone receptors and Human Epidermal Growth Factor Receptor-2 (HER2) available Surgical intervention after completion of neo-adjuvant chemotherapy Evaluable pathological response Exclusion Criteria : Other tumor localization Non controlled diabetes mellitus Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response in M0 patients at baseline PET (stage II-III) | Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of distant metastases (M1 patients at baseline PET) | Detection of distant metastases by FDG PET-CT | 2 weeks | 
| Number of metastatic nodes at baseline PET (axillary and extra-axillary) | Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT | 2 weeks | 
| Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography) |  | 2 weeks | 
| Patients overall survival |  | 5 years | 
| event free survival |  | 5 years | 
| Patients overall survival |  | 3 years | 
| event free survival |  | 3 years | 
| Patients overall survival |  | 2 years | 
| event free survival |  | 2 years | 
| Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography) |  | 2 weeks | 
| Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography) |  | 2 weeks | 
| Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography) |  | 2 weeks |