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

Recruitingn/aAges 18 Years - anyFemaleCentre Hospitalier Universitaire de Besancon
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In plain words

What the trial is, and whether it could suit you

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®.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

5 sites
CHU Besançon
Besançon, France
Clinique Tivoli Ducos
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
AP-HP - Hôpital Tenon
Paris, France
Centre Catalan d'Oncologie
Perpignan, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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