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

Breast Cancer Clinical Trial

Official title:

A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies, Inc. Breast Cancer Intrinsic Subtype Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974856
• Other study ID #: PTL-00172
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: September 14, 2015
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: NanoString Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• 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 test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 2015
• Est. primary completion date: October 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)

• 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 women 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

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Kiel	Kiel
Germany	Universitätsfrauenklinik Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
NanoString Technologies, Inc.

Country where clinical trial is conducted

Germany, 

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