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

Breast Cancer Clinical Trial

— FREDO-ODX-23  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185569
• Other study ID #: 2023/804
• Status: Recruiting
• Start date: October 15, 2023
• Est. completion date: March 2029

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Elise ROBERT
• Phone: +33381219086
• Email: e1robert[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: March 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Locations

Country	Name	City	State
France	CHU Besançon	Besançon
France	Clinique Tivoli Ducos	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	AP-HP - Hôpital Tenon	Paris
France	Centre Catalan d'Oncologie	Perpignan

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breast cancer-specific survival		time between surgery and death related to breast cancer, assessed up to 5 years
Secondary	Distant disease-free survival		time between surgery and distant recurrence or death (all causes), whichever occurs first, assessed up to 5 years
Secondary	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
Secondary	Overall Survival		time between surgery and death, assessed up to 5 years