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. (REVER)

I

Institut Claudius Regaud

Status

Terminated

Conditions

HER2-positive Breast Cancer

Treatments

Other: 2 FES-PET Imaging will be performed:

Study type

Interventional

Funder types

Other

Identifiers

NCT03619044
18 SEIN 08

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

Patients with metastatic breast cancer
Other group
Description:
Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line.
Treatment:
Other: 2 FES-PET Imaging will be performed:

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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