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. (REVER)

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.

Study Overview

• Status: Terminated
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Other: 2 FES-PET Imaging will be performed:

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Albi, France, 81000
    • Clinique Claude Bernard
  • Auch, France, 32008
    • Centre Hospitalier Auch
  • Quint-fonsegrives, France, 31130
    • Clinique Capio La Croix Du Sud
  • Rodez, France, 12000
    • Centre Hospitalier de Rodez
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Toulouse, France, 31059
    • IUCT-O

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. 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).
3. Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
4. Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
5. OMS ≤ 2.
6. For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
7. Patient affiliated to a Social Health Insurance in France.
8. Patient must provide written informed consent prior to any study specific procedures.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with metastatic breast cancer; Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line.	Other: 2 FES-PET Imaging will be performed: before treatment initiation; before treatment cycle 3 initiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of patients with conversion of FES negative lesions in FES positive lesions.	Cycle 3 Day 1 for each patient.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Actual): June 11, 2021
• Study Completion (Actual): July 9, 2021

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Metastatic breast cancer; HER2-positive Breast Cancer; FES-PET
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 18 SEIN 08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No