The Use of FES-PET Imaging as a Tool to Detect a Possible... | NCT03619044

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment rate

Expanded Access Info

Start Date

Aug 28, 2020Actual

Primary Completion Date

Jun 11, 2021Actual

Completion Date

Jul 9, 2021Actual

First Submitted Date

Aug 1, 2018

First Submission Date that Met QC Criteria

Aug 1, 2018

First Posted Date

Aug 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2022

Last Update Posted Date

Feb 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
2 FES-PET Imaging will be performed:	Other	before treatment initiation before treatment cycle 3 initiation	Patients with metastatic breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of patients with conversion of FES negative lesions in FES positive lesions.		Cycle 3 Day 1 for each patient.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Claude Bernard		Albi		81000	France
Centre Hospitalier Auch

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases