Status:
COMPLETED
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay
Lead Sponsor:
NanoString Technologies, Inc.
Collaborating Sponsors:
Cedar Associates LLC
Illumina, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
Brief Summary
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 ad...
Detailed Description
Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before an...
Eligibility Criteria
Inclusion
- 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 females, which is 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT01899079
Start Date
June 1 2013
End Date
July 1 2014
Last Update
March 19 2015
Active Locations (7)
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1
Consorci Sanitari de Terrassa
Barcelona, Spain
2
Corporacio Sanitaria Parc Tauli
Barcelona, Spain
3
Hospital U. Vall D'Hebron
Barcelona, Spain
4
Hospital U. Arnau de Vilanova
Lleida, Spain