Impact of Recurrence Score on Treatment Decisions in Breast Cancer
Impact of Recurrence Score on Adjuvant Treatment Decisions and Tumor Cell Dissemination in Estrogen-receptor Positive and HER2 Negative Patients With Early Breast Cancer
This study looks at how the OncotypeDX Recurrence Score affects treatment choices for women with early-stage breast cancer to see if it helps doctors decide the best care for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tübingen, BW) |
| Trial ID | NCT03961880 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess how the OncotypeDX Recurrence Score influences adjuvant therapy recommendations for women with non-metastatic invasive breast cancer. It will categorize patients based on their Recurrence Score into low, intermediate, and high-risk groups, and evaluate the impact of these scores on tumor cell dissemination. The study will focus on patients who are ER-/PR-positive and HER2-negative, with a nodal status of N0-N1. The research is conducted at the University Hospital Tuebingen, where participants will provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with unilateral primary non-metastatic invasive breast cancer who meet specific hormonal receptor and nodal status criteria.
Not a fit: Patients with ER-negative or HER2-positive breast cancer, or those with advanced disease, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment plans for breast cancer patients.
How similar studies have performed: Previous studies utilizing the OncotypeDX Recurrence Score have shown promising results in guiding treatment decisions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women ≥ 18 years of age * histologically proven unilateral primary non-metastatic invasive breast cancer * ER-/ or PR- positive and HER2-negative * N0-N1 (0-3 involved lymph-nodes). The nodal status may be evaluated clinically. * surgery or planed surgery at the Department of women's health, Tuebingen * written informed consent into IRMA Exclusion Criteria: * ER-negative * HER2-positive * \> 3 involved lymph-nodes * bilateral breast cancer * preexisting cancer disease within the last 10 years * preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria) * primary systemic therapy * locally advanced, inoperable or metastatic breast cancer * pregnant or lactating patients * inadequate general condition (not fit for chemotherapy)
Where this trial is running
Tübingen, BW
- Department for Women's Health — Tübingen, Bw, Germany (Recruiting)
Study contacts
- Study coordinator: Andreas Hartkopf, MD
- Email: andreas.hartkopf@med.uni-tuebingen.de
- Phone: 4970712982211
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.