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

March 17, 2015 updated by: NanoString Technologies, Inc.

Prospective Observational Study to Evaluate the Impact of the Determination of the Intrinsic Subtypes of Breast Cancer by PAM50 NanoString Technology in the Use of Adjuvant Chemotherapy in Women With Breast Cancer, HR+ and Node -.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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 Prosigna test.

Study Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Corporacio Sanitaria Parc Tauli
      • Barcelona, Spain
        • Consorci Sanitari de Terrassa
      • Barcelona, Spain
        • Hospital U. Vall D'Hebron
      • Lleida, Spain
        • Hospital U. Arnau de Vilanova
      • Madrid, Spain
        • Hospital G.U. Gregorio Marañón
      • Madrid, Spain
        • Hospital Quiron Madrid
      • Madrid, Spain
        • Hospital U. 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)

    1. Estrogen receptor status will be evaluated by Immunohistochemistry (IHC)and more than 1% of stained tumor cells will be considered positive.
    2. HER2 status will be evaluated by (IHC; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.

  • Postmenopausal females, which is defined as:

    1. Natural Amenorrhea > 12 months, regardless of age
    2. Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
    3. Radiological castration with amenorrhea > 3 months, regardless of age
    4. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NanoString Technologies, Inc.

Collaborators

Hospital General Universitario Gregorio Marañon
Cedar Associates LLC
Illumina, Inc.
Grupo Espanol de Investigacion del Cancer de Mama
Spanish Breast Cancer Research Group
Vall d'Hebron Institute of Oncology

Investigators

  • Principal Investigator: Miguel Martin, M.D., Ph.D., Hospital General Universitario Gregorio Marañon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTL-00163

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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