Clinical trial · Observational
PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
NCT01617954CI-TRIAL-00020717PROMIScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective study that will assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions in patients with an Oncotype Intermediate Score.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor Positive Malignant Neoplasm of Breast | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MammaPrint | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects with MammaPrint Result
- interventionNames
- Device: MammaPrint
Primary outcomes (1)
- measure
- Difference in recommended adjuvant chemotherapy treatment
- timeFrame
- 30 days
- description
- The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result. A Chi-square test will be performed for the comparison of the two proportions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Women with histologically proven invasive stage I-II, node negative, hormone receptor positive, Her2 negative breast cancer, who received an Oncotype DX intermediate score (18-30) * ≥ 18 years of age at time of consent * Written informed consent Exclusion Criteria: * Insufficient tissue remaining for Mammaprint FFPE * Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria * Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.