FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy (FREDO-ODX-23)

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

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®.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 4500

Contacts and Locations

• Study Contact: Name: Elise ROBERT; Phone Number: +33381219086; Email: e1robert@chu-besancon.fr
• Study Contact Backup: Name: Diane BERTHOD; Phone Number: +33370632403; Email: dberthod@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25030
    • Recruiting
    • CHU Besancon
    • Contact: Elsa CURTIT, MD
  • Bordeaux, France, 33000
    • Recruiting
    • Clinique Tivoli Ducos
    • Contact: Delphine GARBAY, MD
  • Bordeaux, France, 33300
    • Recruiting
    • Polyclinique Bordeaux Nord Aquitaine
    • Contact: Nadine Dohollou, MD
  • Paris, France, 75610
    • Recruiting
    • AP-HP - Hopital Tenon
    • Contact: Marc-Antoine BENDERRA, MD
  • Perpignan, France, 66000
    • Not yet recruiting
    • Centre Catalan d'Oncologie
    • Contact: Nicolas LEDUC, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Breast cancer-specific survival	time between surgery and death related to breast cancer, assessed up to 5 years
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
Overall Survival	time between surgery and death, assessed up to 5 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Elsa CURTIT, Centre Hospitalier Universitaire de Besançon

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Early breast cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• Other Study ID Numbers: 2023/804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No