Assessing outcomes in early breast cancer patients guided by Oncotype DX

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.