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

Breast Cancer Clinical Trial

— ASAINT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02599974
• Other study ID #: NI 12020 ASAINT
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2015
• Last updated: September 28, 2016
• Start date: January 2006

Study information

• Verified date: September 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: David Groheux, MD-PHD
• Phone: 630603009
• Email: david.groheux[@]sls.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Positron-Emission Tomography

Locations

Country	Name	City	State
France	Hopital siant-Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of distant metastases (M1 patients at baseline PET)	Detection of distant metastases by FDG PET-CT	2 weeks	No
Secondary	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	No
Secondary	Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)		2 weeks	No
Secondary	Patients overall survival		5 years	No
Secondary	event free survival		5 years	No
Secondary	Patients overall survival		3 years	No
Secondary	event free survival		3 years	No
Secondary	Patients overall survival		2 years	No
Secondary	event free survival		2 years	No
Secondary	Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)		2 weeks	No
Secondary	Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)		2 weeks	No
Secondary	Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)		2 weeks	No