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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01899079
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-15
• Primary Completion: 2014-01
• Study Completion: 2014-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 217

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result	6 months

Trial Locations

Locations (7)

Consorci Sanitari de Terrassa; 🇪🇸 Barcelona, Spain

Hospital Quirón Madrid; 🇪🇸 Madrid, Spain

Hospital U. Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital U. Arnau de Vilanova; 🇪🇸 Lleida, Spain

Hospital U. 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital G.U. Gregorio Maranon; 🇪🇸 Madrid, Spain

Corporacio Sanitaria Parc Tauli; 🇪🇸 Barcelona, Spain