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

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06185569
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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®.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-10-15
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-29
• Last Update Posted: 2023-12-29
• Primary Completion: 2028-09
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 4500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Distant disease-free survival	time between surgery and distant recurrence or death (all causes), whichever occurs first, assessed up to 5 years
Locoregional relapse-free survival	time between surgery and progression/recurrence (local, regional), ipsilateral DCIS or death (all causes), whichever occurs first, assessed up to 5 years
Breast cancer-specific survival	time between surgery and death related to breast cancer, assessed up to 5 years
Overall Survival	time between surgery and death, assessed up to 5 years

Trial Locations

Locations (5)

CHU Besançon; 🇫🇷 Besançon, France

Centre Catalan d'Oncologie; 🇫🇷 Perpignan, France

Clinique Tivoli Ducos; 🇫🇷 Bordeaux, France

AP-HP - Hôpital Tenon; 🇫🇷 Paris, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France