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Recruiting Observational

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

NCT06185569 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-10-15
Last updated
2023-12-29

Condition(s) studied

Breast Cancer

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • to evaluate the clinical outcomes represented by iDFS in French early breast cancer patients with Oncotype DX (ODX) Breast Recurrence Score® (RS) results-guided therapy — time between surgery and recurrence (local, regional, distant), contralateral breast cancer, second cancer or death (all causes), whichever occurs first, assessed up to 5 years

Trial sites (5)

FacilityCityRegionStatus
CHU Besançon Besançon France Recruiting
Clinique Tivoli Ducos Bordeaux France Recruiting
Polyclinique Bordeaux Nord Aquitaine Bordeaux France Recruiting
AP-HP - Hôpital Tenon Paris France Recruiting
Centre Catalan d'Oncologie Perpignan France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06185569 on ClinicalTrials.gov ↗ ← All trials in France