Clinical trial NCT06185569: FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
Official title: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
Early breast cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 4500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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®.


Eligibility criteria: 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 outcomes:
measure: 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
timeFrame: 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 outcomes:
measure: Breast cancer-specific survival
timeFrame: time between surgery and death related to breast cancer, assessed up to 5 years
measure: Distant disease-free survival
timeFrame: time between surgery and distant recurrence or death (all causes), whichever occurs first, assessed up to 5 years
measure: Locoregional relapse-free survival
timeFrame: time between surgery and progression/recurrence (local, regional), ipsilateral DCIS or death (all causes), whichever occurs first, assessed up to 5 years
measure: Overall Survival
timeFrame: time between surgery and death, assessed up to 5 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: Clinique Tivoli Ducos
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Paris
country: France
facility: AP-HP - Hôpital Tenon
city: Perpignan
country: France
facility: Centre Catalan d'Oncologie
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Elsa CURTIT
role: PRINCIPAL_INVESTIGATOR
References: