A Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay
NCT ID: NCT02395575
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2015-03-31
2017-10-31
Brief Summary
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Detailed Description
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* The evaluation of the confidence in the therapeutic indications of the practitioners before and after the test (assay) results, and by subgroups of cancers
* The evaluation of the rate of secondary effects of chemotherapy,
* The evaluation of the emotional state of patients faced with the therapeutic decision, of their degree of anxiety and of their functional status before and after the Prosigna test (assay) results
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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Institut Curie
OTHER
NanoString Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Roman Rouzier, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie
Locations
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Institut Curie
Paris, , France
Countries
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Other Identifiers
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PTL-10018
Identifier Type: -
Identifier Source: org_study_id