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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Universitätsklinikum Kiel, Kiel, Germany

About this study

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 and after the test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

NanoString Technologies, Inc.

Industry

Registry information

Official study title

A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies, Inc. Breast Cancer Intrinsic Subtype Test

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Nov 4, 2013
Registry last updated: Sep 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed