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

NCT01974856 | Completed

• 1 other identifier: PTL-00172
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 2

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.

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 result.

  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

Study Sites (2)

Universitätsklinikum Kiel

Kiel, 24105, Germany

Location

Universitätsfrauenklinik Ulm

Ulm, 89081, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE samples from breast tumor tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Nadia Harbeck, MD, PhD

  Leitung des Brustzentrums der Universität München

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 4, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

DE (2)