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Keep this study
Lead
NanoString Technologies, Inc.
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.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Surgically resected node-negative, estrogen receptor-positive, HER2-negative early-stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)
1. Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive.
2. 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:
1. Natural Amenorrhea \> 12 months, regardless of age
2. Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
3. Radiological castration with amenorrhea \> 3 months, regardless of age
4. 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 be 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
Clareo Health | Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients
