Assessing outcomes in early breast cancer patients guided by Oncotype DX
FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
This study is testing how well treatment guided by the Oncotype DX test works for women with early hormone receptor-positive, HER2-negative breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Besançon and 4 other locations) |
| Trial ID | NCT06185569 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical outcomes of early breast cancer patients who are hormone receptor-positive and HER2-negative, specifically focusing on those whose treatment is guided by the Oncotype DX Breast Recurrence Score. The study will collect real-life data from patients diagnosed with operable breast cancer and who have undergone the Oncotype DX assay. By analyzing these outcomes, the study seeks to provide insights into the effectiveness of recurrence score-guided therapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older with operable, hormone receptor-positive, HER2-negative breast cancer who have undergone the Oncotype DX assay.
Not a fit: Patients with inoperable tumors, metastatic breast cancer, or those who have undergone neoadjuvant chemotherapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for early breast cancer patients, leading to improved patient outcomes.
How similar studies have performed: Other studies utilizing Oncotype DX for guiding therapy in breast cancer have shown promising results, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Besançon and 4 other locations
- CHU Besançon — Besançon, France (Recruiting)
- Clinique Tivoli Ducos — Bordeaux, France (Recruiting)
- Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Recruiting)
- AP-HP - Hôpital Tenon — Paris, France (Recruiting)
- Centre Catalan d'Oncologie — Perpignan, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Elsa CURTIT — Centre Hospitalier Universitaire de Besancon
- Study coordinator: Elise ROBERT
- Email: e1robert@chu-besancon.fr
- Phone: +33381219086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.