Clinical trial NCT02599974: PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Positron-Emission Tomography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with large breast cancer treated with neo-adjuvant chemotherapy regimen.

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.


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

Primary outcomes:
measure: Pathological complete response in M0 patients at baseline PET (stage II-III)
timeFrame: 18 weeks
Secondary outcomes:
measure: Number of distant metastases (M1 patients at baseline PET)
timeFrame: 2 weeks
measure: Number of metastatic nodes at baseline PET (axillary and extra-axillary)
timeFrame: 2 weeks
measure: Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
timeFrame: 2 weeks
measure: Patients overall survival
timeFrame: 5 years
measure: event free survival
timeFrame: 5 years
measure: Patients overall survival
timeFrame: 3 years
measure: event free survival
timeFrame: 3 years
measure: Patients overall survival
timeFrame: 2 years
measure: event free survival
timeFrame: 2 years
measure: Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
timeFrame: 2 weeks
measure: Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
timeFrame: 2 weeks
measure: Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital siant-Louis
Study officials:
affiliation: DRCD APHP Paris
name: Matthieu Resche-Rigon, MD-PHD
role: STUDY_CHAIR
affiliation: APHP, IUH, University Paris Diderot, Paris 7, SPC
name: David Groheux, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: