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

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02625935

Run by

NanoString Technologies, Inc.

People needed

206

Starts

2015-12-01

Expected to finish

2017-10-10

Last updated by the study team

2017-10-13

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Florida Cancer Center — Fort Myers, Florida, United States
• New England Cancer Specialists — Scarborough, Maine, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• North Shore Hematology Oncology Assoaciates — East Setauket, New York, United States

Full record on ClinicalTrials.gov

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