Clinical trial NCT03619044: 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.
Official title: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HER2-positive Breast Cancer
Keywords: Metastatic breast cancer
FES-PET
HER2-positive Breast Cancer
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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), 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.

Primary outcomes:
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:
measure: The rate of patients with FES positive lesions before treatment.
timeFrame: Cycle 4 Day 1 for each patient.
measure: 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.
timeFrame: Cycle 4 Day 1 for each patient.
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Auch
country: France
facility: Centre Hospitalier Auch
city: Quint-fonsegrives
country: France
facility: Clinique Capio La Croix Du Sud
city: Rodez
country: France
facility: Centre Hospitalier de Rodez
city: Toulouse
country: France
facility: IUCT-O
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
References: