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.

NCT03619044 | Terminated

• 1 other identifier: 18 SEIN 08
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 6

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.

Conditions

HER2-positive Breast Cancer

Keywords

Metastatic breast cancer; FES-PET; HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The rate of patients with conversion of FES negative lesions in FES positive lesions.

  Cycle 3 Day 1 for each patient.

Secondary Outcomes (2)

• The rate of patients with FES positive lesions before treatment.

  Cycle 4 Day 1 for each patient.

• 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.

Study Arms (1)

Patients with metastatic breast cancer

OTHER

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

Other: 2 FES-PET Imaging will be performed:

Interventions

2 FES-PET Imaging will be performed: OTHER

* before treatment initiation * before treatment cycle 3 initiation

Patients with metastatic breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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).
• Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
• Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
• OMS ≤ 2.
• For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
• Patient affiliated to a Social Health Insurance in France.
• Patient must provide written informed consent prior to any study specific procedures.

You may not qualify if:

• Any previous treatment for metastatic disease.
• Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
• Patient with isolated hepatic metastasis.
• Patient with hemostasis disorders.
• Unbalanced Diabetes.
• Patient with usual formal contraindication to PET/TDM Imaging.
• Patient who has already started trastuzumab + pertuzumab + taxane treatment.
• Pregnant or breastfeeding women.
• Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
• Patient protected by law.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (6)

Clinique Claude Bernard

Albi, 81000, France

Location

Centre Hospitalier Auch

Auch, 32008, France

Location

Clinique Capio La Croix Du Sud

Quint-Fonsegrives, 31130, France

Location

Centre Hospitalier de Rodez

Rodez, 12000, France

Location

IUCT-O

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: August 28, 2020
• Primary Completion: June 11, 2021
• Study Completion: July 9, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-01

Locations

FR (6)