NCT06185569

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®.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Oct 2023Mar 2029

Study Start

First participant enrolled

October 15, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

December 29, 2023

Status Verified

August 1, 2023

Enrollment Period

4.9 years

First QC Date

October 16, 2023

Last Update Submit

December 14, 2023

Conditions

Breast Cancer

Keywords

Breast CancerEarly breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Besançon

Besançon, 25030, France

RECRUITING

Clinique Tivoli Ducos

Bordeaux, 33000, France

RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

RECRUITING

AP-HP - Hôpital Tenon

Paris, 75610, France

RECRUITING

Centre Catalan d'Oncologie

Perpignan, 66000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elsa CURTIT

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise ROBERT

CONTACT

+33381219086e1robert@chu-besancon.fr

Diane BERTHOD

CONTACT

+33370632403dberthod@chu-besancon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

December 29, 2023

Study Start

October 15, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

December 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)