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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2021-07-09

Brief Summary

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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.

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Detailed Description

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Conditions

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HER2-positive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with metastatic breast cancer

Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line.

Group Type OTHER

2 FES-PET Imaging will be performed:

Intervention Type OTHER

* before treatment initiation
* before treatment cycle 3 initiation

Interventions

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2 FES-PET Imaging will be performed:

* before treatment initiation
* before treatment cycle 3 initiation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No