Clinical trial · Observational
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies, Inc. Breast Cancer Intrinsic Subtype Test
NCT01974856CI-TRIAL-00019133completedClinicalTrials.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 assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with 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 result.
- 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.