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FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy

NCT ID: NCT06185569

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2029-03-31

Brief Summary

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The aim of this study is to assess the clinical outcomes in real-life setting of early breast cancer RH+ HER2- patients with systemic therapy guided by Oncotype DX (ODX) Breast Recurrence Score®.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Breast Cancer Early breast cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 18 years old With invasive breast carcinoma diagnosed on biopsy or surgical sample (histological evidence) Operable breast cancer HR+ (at least ER+) /HER2- tumors With ODX assay performed

Exclusion Criteria

* Inoperable tumor(s) or inoperable patient (e.g., patient too frail to undergo surgery) Synchronous breast cancers with different clinico-pathological features (e.g. : HR+/HER2 negative and triple-negative or HER2-positive breast cancer Patient undergoing neoadjuvant chemotherapy or neoadjuvant hormone therapy Nodal involvement in more than 4 lymph nodes (pN2 or higher) Metastatic breast cancer at diagnosis Other malignancy diagnosed in the past 10 years (except for cutaneous malignancies other than melanoma) The patient participated in the RxPONDER study in France The patient communicated a refusal to participate in the study (via a refusal letter to the investigator) Legal incapacity or limited legal capacity
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elsa CURTIT

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Locations

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CHU Besançon

Besançon, , France

Site Status RECRUITING

Clinique Tivoli Ducos

Bordeaux, , France

Site Status RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Site Status RECRUITING

AP-HP - Hôpital Tenon

Paris, , France

Site Status RECRUITING

Centre Catalan d'Oncologie

Perpignan, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Elise ROBERT

Role: CONTACT

Phone: +33381219086

Email: [email protected]

Diane BERTHOD

Role: CONTACT

Phone: +33370632403

Email: [email protected]

Facility Contacts

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Elsa CURTIT, MD

Role: primary

Delphine GARBAY, MD

Role: primary

Nadine DOHOLLOU, MD

Role: primary

Marc-Antoine BENDERRA, MD

Role: primary

Nicolas LEDUC, MD

Role: primary

Other Identifiers

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2023/804

Identifier Type: -

Identifier Source: org_study_id