NCT01899079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

July 10, 2013

Last Update Submit

March 17, 2015

Conditions

Breast Cancer

Keywords

Breast CancerProsignaFFPEnode negativeestrogen receptor positiveHER2 negative

Outcome Measures

Primary Outcomes (1)

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

    6 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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 females, which is 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Consorci Sanitari de Terrassa

Barcelona, Spain

Location

Corporacio Sanitaria Parc Tauli

Barcelona, Spain

Location

Hospital U. Vall D'Hebron

Barcelona, Spain

Location

Hospital U. Arnau de Vilanova

Lleida, Spain

Location

Hospital G.U. Gregorio Maranon

Madrid, Spain

Location

Hospital Quirón Madrid

Madrid, Spain

Location

Hospital U. 12 de Octubre

Madrid, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE breast tumor tissue samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Miguel Martin, M.D., Ph.D.

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 15, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

July 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

ES(7)