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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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HER2-positive Breast Cancer

Intervention / Treatment
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* Other: 2 FES-PET Imaging will be performed:


Participation Criteria
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Eligibility Criteria
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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). OMS ≤ 2. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FES-PET, Metastatic breast cancer, HER2-positive Breast Cancer