Actively Recruiting
FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2023-12-29
4500
Participants Needed
5
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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®.
CONDITIONS
Official Title
FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years old or older
- Diagnosed with invasive breast carcinoma confirmed by biopsy or surgical sample
- Operable breast cancer that is hormone receptor-positive (at least estrogen receptor-positive) and HER2-negative
- Oncotype DX assay performed to guide therapy
You will not qualify if you...
- Inoperable tumor or patient too frail for surgery
- Having synchronous breast cancers with different clinical features (e.g., HR+/HER2 negative and triple-negative or HER2-positive breast cancer)
- Undergoing neoadjuvant chemotherapy or hormone therapy
- More than 4 lymph nodes involved (pN2 or higher)
- Metastatic breast cancer at diagnosis
- Other malignancy diagnosed in the past 10 years except non-melanoma skin cancer
- Participation in the RxPONDER study in France
- Refusal to participate communicated to investigator
- Legal incapacity or limited legal capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
CHU Besançon
Besançon, France, 25030
Actively Recruiting
2
Clinique Tivoli Ducos
Bordeaux, France, 33000
Actively Recruiting
3
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Actively Recruiting
4
AP-HP - Hôpital Tenon
Paris, France, 75610
Actively Recruiting
5
Centre Catalan d'Oncologie
Perpignan, France, 66000
Not Yet Recruiting
Research Team
E
Elise ROBERT
CONTACT
D
Diane BERTHOD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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