HER2-positive Breast Cancer
Conditions
Keywords
Metastatic breast cancer, FES-PET, HER2-positive Breast Cancer
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.
Interventions
OTHER2 FES-PET Imaging will be performed:
* before treatment initiation * before treatment cycle 3 initiation
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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. |
Countries
France
Outcome results
None listed