FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
Recruiting now
Conditions studied: Breast Cancer
In brief
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®.
Key facts
- Study ID
- NCT06185569
- Run by
- Centre Hospitalier Universitaire de Besancon
- People needed
- 4500
- Starts
- 2023-10-15
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2023-12-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHU Besançon — Besançon, France (enrolling)
- Clinique Tivoli Ducos — Bordeaux, France (enrolling)
- Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (enrolling)
- AP-HP - Hôpital Tenon — Paris, France (enrolling)
- Centre Catalan d'Oncologie — Perpignan, France
Full record on ClinicalTrials.gov
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