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Completed

NCT Number: NCT01974856

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

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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

  1. 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.

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