Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06195709

ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients

Led by Institut Curie · Updated on 2026-04-17

300

Participants Needed

21

Research Sites

330 weeks

Total Duration

On this page

Sponsors

I

Institut Curie

Lead Sponsor

Z

Zionexa

Collaborating Sponsor

AI-Summary

What this Trial Is About

Eclectic is a strategy trial; once the class of treatment (endocrine therapy or chemotherapy) has been allocated according to 16α-18F-fluoro-17β-oestradiol (18F-FES) Positron Emission Tomography/Computed Tomography (PET/CT) results and circulating tumor biomarkers, clinicians will decide which treatment to use.

CONDITIONS

Official Title

ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Metastatic invasive breast carcinoma of no special type
  • Female or male aged 18 years or older
  • Life expectancy longer than 3 months
  • ECOG performance status 0 to 2
  • ER-positive (at least 10%) and HER2-negative breast cancer per local assessment
  • Available tumor tissue block (primary tumor or metastasis)
  • Disease progressed on first line endocrine therapy with aromatase inhibitor and CDK4/6 inhibitor after more than 6 months
  • Available 18F-FDG PET/CT imaging
  • Evaluable disease per RECIST and measurable disease per PERCIST criteria
  • Willing and able to follow scheduled visits, treatment plan, and protocol procedures
  • Signed informed consent
  • Affiliated with a social security system
Not Eligible

You will not qualify if you...

  • Breast cancer subtype other than no special type (e.g., invasive lobular breast carcinoma)
  • Any prior chemotherapy lines in metastatic setting
  • Any systemic treatment other than first line endocrine therapy with aromatase inhibitor and CDK4/6 inhibitor for metastatic disease
  • Visceral crisis as assessed by investigator
  • Liver-only metastases
  • Prior use of agents degrading the estrogen receptor (fulvestrant, oral SERDs, PROTAC, etc.)
  • Pregnancy or breastfeeding
  • Women of childbearing potential or premenopausal women without adequate non-hormonal contraception
  • Positive pregnancy test within 72 hours before 18F-FES PET/CT
  • Active uncontrolled or symptomatic central nervous system metastases or related conditions, unless treated and stable for at least 4 weeks
  • History of other cancers or blood cancers within 3 years before enrollment, except multiple primary ER+ HER2- breast tumors
  • Persons deprived of liberty, under guardianship, or unable to consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 21 locations

1

Centre Hospitalier de la Côte basque

Bayonne, France, 64100

Not Yet Recruiting

2

Institut Bergonié

Bordeaux, France, 33076

Not Yet Recruiting

3

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France, 33077

Not Yet Recruiting

4

Centre Francois Baclesse

Caen, France, 14076

Actively Recruiting

5

Centre Georges Francois Leclerc

Dijon, France, 21079

Actively Recruiting

6

Centre Oscar Lambret

Lille, France, 59000

Actively Recruiting

7

CHU Limoges

Limoges, France, 87000

Not Yet Recruiting

8

Centre Leon Bérard

Lyon, France, 69008

Not Yet Recruiting

9

Institut Paoli-Calmettes

Marseille, France, 13009

Actively Recruiting

10

Institut du Cancer Montpellier

Montpellier, France, 34298

Actively Recruiting

11

Centre Antoine lacassagne

Nice, France, 06189

Actively Recruiting

12

Hôpital Universitaire de Nimes

Nîmes, France, 30029

Not Yet Recruiting

13

Institut Curie

Paris, France, 75005

Actively Recruiting

14

Centre Eugène Marquis

Rennes, France, 35042

Actively Recruiting

15

Centre Henri Becquerel

Rouen, France, 76038

Not Yet Recruiting

16

Institut Curie

Saint-Cloud, France, 92210

Actively Recruiting

17

Bruno MAUCHERAT

Saint-Herblain, France, 44805

Withdrawn

18

Centre de lutte contre le cancer Paul Strauss

Strasbourg, France

Not Yet Recruiting

19

Oncopole Claudius Regaud

Toulouse, France, 31059

Not Yet Recruiting

20

Hôpital Bretonneau-CHU Tours

Tours, France, 37044

Not Yet Recruiting

21

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France, 54519

Actively Recruiting

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Research Team

F

François-Clément BIDARD, PhD

CONTACT

I

Isabelle TURBIEZ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients | DecenTrialz