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.

HER2-positive Breast Cancer Clinical Trial

— REVER  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03619044
• Other study ID #: 18 SEIN 08
• Status: Terminated
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: July 9, 2021

Study information

• Verified date: January 2022
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 9, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Other:
• 2 FES-PET Imaging will be performed:
before treatment initiation before treatment cycle 3 initiation

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Albi
France	Centre Hospitalier Auch	Auch
France	Clinique Capio La Croix Du Sud	Quint-fonsegrives
France	Centre Hospitalier de Rodez	Rodez
France	Clinique Pasteur	Toulouse
France	IUCT-O	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients with conversion of FES negative lesions in FES positive lesions.		Cycle 3 Day 1 for each patient.
Secondary	The rate of patients with FES positive lesions before treatment.		Cycle 4 Day 1 for each patient.
Secondary	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.		Cycle 4 Day 1 for each patient.