Clinical trial · Observational
A Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay
Prospective Study Evaluating the Clinical Impact of the Breast Cancer Intrinsic Subtype-Prosigna Test (Assay) in the Management of Early-stage Breast Cancers
NCT02395575CI-TRIAL-00029896completedClinicalTrials.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)
The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test results.
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0) * Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive. * HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization. * Postmenopausal women defined as: * Natural Amenorrhea \> 12 months, regardless of age * Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study) * Radiological castration with amenorrhea \> 3 months, regardless of age * Hysterectomy and postmenopausal blood levels * Able to give consent * Eligible for treatment of breast cancer with adjuvant chemotherapy * ECOG performance status of 0 or 1 Exclusion Criteria: * Tumor size T3-T4 * Non-invasive breast cancer (e.g., Paget's disease, DCIS) * Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+) * Tumors that are estrogen-receptor negative or HER2 positive * Have metastatic disease * Unable to give informed consent * Unable to complete patient reported outcome surveys * Have contraindications for adjuvant chemotherapy * Age, performance status, significant comorbidities * ECOG performance status \> 1
References
Publications (0)
Data not yet available
No reference posted for this study.