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

Breast Cancer Clinical Trial

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 -.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899079
• Other study ID #: PTL-00163
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: March 17, 2015
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: NanoString Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of HealthSpain: Departament de Salut de la Generalitat de CatalunyaSpain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
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

Sponsors (7)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result		6 months	No