Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients
- Conditions
- Breast Cancer
- Registration Number
- NCT02625935
- Lead Sponsor
- NanoString Technologies, Inc.
- 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.
- Detailed Description
The primary objective of this study is to assess the extent to which the Prosigna test results affect the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early stage breast cancer conventionally considered candidates for genomic testing based on current treatment guidelines. The oncologist's initial recommendations will be based on the utilization of tools or algorithms based on clinical and pathologic factors. No genomic tools will be used in the initial assessment. Changes in recommendation after availability of Prosigna test results will include (1) hormonal therapy alone or (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 206
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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
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients for whom the choice of treatment was changed as a result of receiving the Prosigna test results. 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
North Shore Hematology Oncology Assoaciates
🇺🇸East Setauket, New York, United States
Florida Cancer Center
🇺🇸Fort Myers, Florida, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States