The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.

Institut Claudius Regaud6 sites in 1 country4 target enrollmentAugust 28, 2020

ConditionsHER2-positive Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HER2-positive Breast Cancer
Sponsor: Institut Claudius Regaud
Enrollment: 4
Locations: 6
Primary Endpoint: The rate of patients with conversion of FES negative lesions in FES positive lesions.
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.

For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).

Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.

Patients will be followed during the 3 cycles of treatment.

Registry

clinicaltrials.gov

Start Date

August 28, 2020

End Date

July 9, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Institut Claudius Regaud

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years.
•Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
•Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
•Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
•For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
•Patient affiliated to a Social Health Insurance in France.
•Patient must provide written informed consent prior to any study specific procedures.

Exclusion Criteria

•Any previous treatment for metastatic disease.
•Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
•Patient with isolated hepatic metastasis.
•Patient with hemostasis disorders.
•Unbalanced Diabetes.
•Patient with usual formal contraindication to PET/TDM Imaging.
•Patient who has already started trastuzumab + pertuzumab + taxane treatment.
•Pregnant or breastfeeding women.
•Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
•Patient protected by law.

Outcomes

Primary Outcomes

The rate of patients with conversion of FES negative lesions in FES positive lesions.

Time Frame: Cycle 3 Day 1 for each patient.

Secondary Outcomes

The rate of patients with FES positive lesions before treatment.(Cycle 4 Day 1 for each patient.)
The adverse events due to FES-PET imaging evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.(Cycle 4 Day 1 for each patient.)