Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients

NCT02625935 | Completed

• 1 other identifier: PTL-10140
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 4

Brief Summary

This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors. This study also examines the impact of the test results on patients' reported outcomes, including their decisional conflict status and anxiety levels.

Conditions

Breast Cancer

Keywords

Prosigna; estrogen receptor positive; node negative; HER2 negative

Outcome Measures

Primary Outcomes (1)

• The proportion of patients for whom the choice of treatment was 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.

You may qualify if:

• Surgically 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 and/or by in-situ fluorescence hybridization (0 or 1+, or 2+ will be considered negative in the absence of in-situ fluorescence hybridization).
• Postmenopausal females, which is 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 of FSH/LH
• Able to give informed consent
• Eligible for treatment of breast cancer with adjuvant chemotherapy, as determined by the treating physician
• ECOG performance status of 0 or 1

You may not qualify if:

• Tumor specimen from core needle biopsy (CNB)
• Tumor stage 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 (ER) negative or HER2-positive
• Have metastatic disease
• Have received another genomic test for prognosis of early breast cancer (i.e., Oncotype Dx, Mammaprint, or BCI)
• Unable to give informed consent
• Unable to complete patient reported outcome surveys
• Have contraindications for adjuvant chemotherapy, as determined by the treating physician
• o Age, performance status, significant comorbidities, etc.
• ECOG performance status \> 1

Sponsors & Collaborators

• NanoString Technologies, Inc.: lead

Study Sites (4)

Florida Cancer Center

Fort Myers, Florida, 33913, United States

Location

New England Cancer Specialists

Scarborough, Maine, 04074, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

North Shore Hematology Oncology Assoaciates

East Setauket, New York, 11733, United States

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

• Jeffrey Vacirca, MD

  North Shore Hematology Oncology Associates

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 9, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: October 10, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-04

Locations

US (4)