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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06185569
Other study ID # 2023/804
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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