Impact of 18F-FES TEP on therapeutical management in patients with metastatic breast cancer, ER positive and HER2 negative, in relapse after a first line of treatment combining hormonal therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GE Healthcare Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Diseases [C] - Neoplasms [C04]

Trial duration

24 Oct 2024 → 27 Dec 2025

Decision date (initial)

2024-10-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517400-11-00

EudraCT number

2021-003601-21

ClinicalTrials.gov

NCT05486182

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To assess the impact of FES PET/CT on the management of patients with metastatic breast cancer initially presenting with overexpression of oestrogen receptors (ER) and absence of HER2 overexpression, in relapse after first-line treatment combining hormone therapy.

Secondary objectives 4

1. 1. Evaluate the impact of substantial therapeutic measures on progression-free survival of the 2nd midline, with constitution of a historical group
2. 2. Determine the relevance at 3 months of the therapeutic measures put in place following the FES PET / CT performed at baseline
3. 3. Identify parameters of FES PET / CT associated with substantial therapeutic measure
4. Exploratory analyses: 1. The primary endpoint will be evaluated in the following sub-groups: - The type of breast cancer: ductal or lobular- Oligometastatic disease or not (threshold> 5 lesions) The stage of metastatic disease: metastatic from the outset or recurrent after curative treatment 2. Compare the Quality of life of patients with substantial therapeutic measures versus others

Conditions and MedDRA coding

Patients with metastatic breast cancer initially presenting with overexpression of estrogen receptors (ERs) and absence of overexpression of HER2, relapsing after a first therapeutic line combining hormone therapy.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Woman aged at least 18 years old on inclusion 2. Primary breast cancer expressing hormonal estrogen receptors in IHC (ER ≥ 10%) 3. Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative) 4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a hepatic lesion 5. Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy 6.Patient having performed a PET / CT with FDG during the follow-up of the first metastatic line defining the relapse or performing a PET / CT with the baseline FDG defining the relapse during the extension assessment of 2nd line (according to the recommendations of the GBU of the examinations of 'medical imaging). A period of 2 to 28 days will be respected between the 2 PET / CT (FDG / FES). 7.ECOG 0, 1 or 2 8. Life expectancy of at least 12 months

Exclusion criteria 1

1. 1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES) 2. Patients in the first metastatic line or beyond the second metastatic line 3. Person with a known allergy to any of the components of EstroTep 4. Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD 5. Patient suffering from severe or known hepatic or renal failure 6. Patient under a low salt diet or having an alcohol intake incompatible with EstroTep administration according to the investigator judgment 7.Woman of childbearing potential without effective contraception according to the investigator judgement 8. Serious intercurrent illness or co-morbidity assessed as risk

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. 1. The therapeutic impact will be assessed by the percentage of patients for whom a substantial therapeutic measure has been implemented following the analysis of the PET-FES examination. This evaluation will be done using a standardized questionnaire filled in by the prescribing clinician prospectively, when requesting PET / CT at FES. This questionnaire will be completed again within a maximum of 15 days after the PET / CT FES in order to specify the final therapeutic measure.
2. 1 cont. The treatment modality initially planned and that finally implemented can be determined in the RCP according to thecenters. For the same patient, the questionnaire will be completed by the same investigator. Any modification of:-therapeutic modalities•change in the type of hormone therapy molecule • addition of a hormone therapy molecule • withdrawal of a hormone therapy molecule • change in the type of chemotherapy molecule • addition of a chemotherapy molecule
3. 1 cont.change in the type of other systemic treatment molecule•addition of other type of systemic treatment molecule•withdrawal of other type of systemic treatment molecule•addition of radiotherapy treatment•stopping radiotherapy treatment•change in radiotherapy technique•change in radiotherapy protocol•enlarged irradiation field of an already identified area•restricted irradiation field of an already identified area•programming of surgery•deprogramming of surgery
4. - diagnostic modalities: • addition of a complementary exam • withdrawal of an additional examination • performing a biopsy - monitoring methods • adding an exam • withdrawal of an exam • increased frequency of follow-up • decrease in frequency of follow-up

Secondary endpoints 2

1. 2nd line progression-free survival (PFS) is defined as the time between the date of the final therapeutic measure (treatment decision) and relapse, by comparing the medians of progression-free survival (PFS) in the study population and in the cohort historical. The comparison will be made by the Kaplan Meier test with a 12-month censorship.
2. The relevance of the therapeutic measures put in place following the baseline PET / CT FES will be determined at 3 months on all the data in the patient's medical file (including the evaluation of the response to treatment) of the patient by an independent jury clinicians, made up of expert physician (oncologist, nuclear physician, radiotherapist, radiologist).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GE Healthcare Limited

Sponsor organisation

GE Healthcare Limited

Address

Pollards Wood, Nightingales Lane Nightingales Lane

City

Chalfont St. Giles

Postcode

HP8 4SP

Country

United Kingdom

Scientific contact point

Organisation

GE Healthcare Limited

Contact name

Jo Stevens

Public contact point

Organisation

GE Healthcare Limited

Contact name

Jo Stevens

Third parties 7

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications