Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2 FES-PET Imaging will be performed: | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients with metastatic breast cancer
- description
- Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line.
- interventionNames
- Other: 2 FES-PET Imaging will be performed:
Primary outcomes (1)
- measure
- The rate of patients with conversion of FES negative lesions in FES positive lesions.
- timeFrame
- Cycle 3 Day 1 for each patient.
Secondary outcomes (2)
- measure
- The rate of patients with FES positive lesions before treatment.
- timeFrame
- Cycle 4 Day 1 for each patient.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available