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.

Not Applicable

Terminated

• Conditions: HER2-positive Breast Cancer

• Registration Number: NCT03619044
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-07
• Study Start: 2020-08-28
• Primary Completion: 2021-06-11
• Study Completion: 2021-07-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Centre Hospitalier Auch; 🇫🇷 Auch, France

Clinique Claude Bernard; 🇫🇷 Albi, France

Clinique Capio La Croix Du Sud; 🇫🇷 Quint-fonsegrives, France

IUCT-O; 🇫🇷 Toulouse, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Centre Hospitalier de Rodez; 🇫🇷 Rodez, France