A Study of Clinical Outcomes for the NanoString® Technolo... | NCT02395575

Studies
A Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay

NCT02395575

Sponsor

NanoString Technologies, Inc.

Status

Completed

Last Update Posted

Oct 13, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Oct 2017Actual

First Submitted Date

Mar 17, 2015

First Submission Date that Met QC Criteria

Mar 20, 2015

First Posted Date

Mar 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 13, 2017Actual

Name	Class
Institut Curie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

The secondary objectives will consist of:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Measure	Description	Time Frame
The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test results.		6 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Postmenopausal women with node-negative, estrogen-receptor positive, HER2-negative early-stage breast cancer. Investigators will offer enrollment to consecutively seen women who meet the entry criteria,

Sampling Method

Probability Sample

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases