EUCTR2018-001552-36-FR
Active, not recruiting
Phase 1
The use of FES-PET imaging as a tool to detect a possible reversion of Estrogen Receptor (ER)-a status in patients with metastatic breast cancer HER2 + and ERa neg treated with trastuzumab + pertuzumab + taxane. - REVER
ConditionsMetastatic breast cancer HER2 + and ERa neg.MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsEstroTep®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic breast cancer HER2 + and ERa neg.
- Sponsor
- INSTITUT CLAUDIUS REGAUD
- Enrollment
- 33
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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:
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.
Outcomes
Primary Outcomes
Not specified
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