Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01899079
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : March 19, 2015
Sponsor:
Collaborators:
Cedar Associates LLC
Illumina, Inc.
Grupo Espanol de Investigacion del Cancer de Mama
Spanish Breast Cancer Research Group
Hospital General Universitario Gregorio Marañon
Vall d'Hebron Institute of Oncology
Information provided by (Responsible Party):
NanoString Technologies, Inc.

Brief Summary:
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.

Condition or disease
Breast Cancer

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 217 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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 -.
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
FFPE breast tumor tissue samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899079


Locations
Layout table for location information
Spain
Consorci Sanitari de Terrassa
Barcelona, Spain
Corporacio Sanitaria Parc Tauli
Barcelona, Spain
Hospital U. Vall D'Hebron
Barcelona, Spain
Hospital U. Arnau de Vilanova
Lleida, Spain
Hospital G.U. Gregorio Maranon
Madrid, Spain
Hospital Quirón Madrid
Madrid, Spain
Hospital U. 12 de Octubre
Madrid, Spain
Sponsors and Collaborators
NanoString Technologies, Inc.
Cedar Associates LLC
Illumina, Inc.
Grupo Espanol de Investigacion del Cancer de Mama
Spanish Breast Cancer Research Group
Hospital General Universitario Gregorio Marañon
Vall d'Hebron Institute of Oncology
Investigators
Layout table for investigator information
Principal Investigator: Miguel Martin, M.D., Ph.D. Hospital General Universitario Gregorio Marañón
Layout table for additonal information
Responsible Party: NanoString Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01899079    
Other Study ID Numbers: PTL-00163
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Keywords provided by NanoString Technologies, Inc.:
Breast Cancer
Prosigna
FFPE
node negative
estrogen receptor positive
HER2 negative
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases