Status:
RECRUITING
FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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®.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
4500 Patients enrolled
Trial Details
Trial ID
NCT06185569
Start Date
October 15 2023
End Date
March 1 2029
Last Update
December 29 2023
Active Locations (5)
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1
CHU Besançon
Besançon, France, 25030
2
Clinique Tivoli Ducos
Bordeaux, France, 33000
3
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
4
AP-HP - Hôpital Tenon
Paris, France, 75610