Metastatic breast cancer HER2 + and ERa neg. MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: EstroTep®
Pharmaceutical Form: Solution for injection
Sponsors
INSTITUT CLAUDIUS REGAUD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERa 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 Diabètes. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERa status in patients with metastatic breast cancer HER2 + and ERa neg.;Secondary Objective: The secondary objectives are: - Evaluate if there is a discrepancy between the RE a neg phenotype determined in immuno-histochemistry and by FES-PET imaging before any treatment. - Study the expression of the ER a by FES-PET imaging according to the tumor metastatic sites before and during the anti-HER2 treatment. - Correlate the fixation obtained between FDG-PET and FES-PET imaging before the start of the treatment. - Correlate the fixation obtained in FES-PET imaging before and during the treatment. - Evaluate the adverse effects of FES-PET imaging.;Primary end point(s): The main judgment criterion is the rate of patients with conversion of FES - lesions in FES + lesions. ;Timepoint(s) of evaluation of this end point: Cycle 3 Day 1 for each patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: - The discrepancy rate between the REa neg phenotype determined in immuno-histochemistry and by 18FES-PET imagiging before treatment. - The adverse events due to FES-PET imaging evaluated by the NCI-CTCAE version 4.03. ;Timepoint(s) of evaluation of this end point: Cycle 4 Day 1 for each patient. | — |
Countries
France
Contacts
Public ContactCoordinating Investigator
INSTITUT CLAUDIUS REGAUD
Outcome results
None listed