NCT02599974

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

14.9 years

First QC Date

May 28, 2015

Last Update Submit

September 28, 2016

Conditions

Breast CancerPositron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Number of distant metastases (M1 patients at baseline PET)

    2 weeks

  • Number of metastatic nodes at baseline PET (axillary and extra-axillary)

    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

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with large breast cancer treated with neo-adjuvant chemotherapy regimen.

You may qualify if:

  • 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

You may not qualify if:

  • Other tumor localization
  • Non controlled diabetes mellitus
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital siant-Louis

Paris, Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Matthieu Resche-Rigon, MD-PHD

    DRCD APHP Paris

    STUDY CHAIR

  • David Groheux, MD-PhD

    APHP, IUH, University Paris Diderot, Paris 7, SPC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Groheux, MD-PHD

CONTACT

630603009david.groheux@sls.aphp.fr

Patricia de Cremoux, MD-PHD

CONTACT

142499385patricia.de-cremoux@sls.aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

November 9, 2015

Study Start

January 1, 2006

Primary Completion

December 1, 2020

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

FR(1)