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

NCT02395575 | Completed

• 1 other identifier: PTL-10018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  6 months

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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,

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 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

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

Sponsors & Collaborators

• NanoString Technologies, Inc.: lead
• Institut Curie: collaborator

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE breast tumor tissue samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Roman Rouzier, MD, PhD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 23, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: October 1, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)