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

Breast Cancer Clinical Trial

Official title:

Prospective Study Evaluating the Clinical Impact of the Breast Cancer Intrinsic Subtype-Prosigna Test (Assay) in the Management of Early-stage Breast Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395575
• Other study ID #: PTL-10018
• Status: Completed
• Phase: N/A
• First received: March 17, 2015
• Last updated: October 11, 2017
• Start date: March 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2017
• Source: NanoString Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (2)

Lead Sponsor	Collaborator
NanoString Technologies, Inc.	Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test results.		6 months