Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NanoString Technologies, Inc.
With
Cedar Associates LLC
Illumina, Inc.
Grupo Espanol de Investigacion del Cancer de Mama
Spanish Breast Cancer Research Group
Hospital General Universitario Gregorio Marañon
Vall d'Hebron Institute of Oncology
Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the Prosigna test.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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; 0 or 1+, or 2+ will be considered negative) and by 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
Able to give consent
Eligible for treatment of breast cancer with adjuvant chemotherapy
ECOG performance status of 0 or 1
You may not be 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
