Metadata supporting data files in the published article: The Prosigna 50-gene profile and responsiveness to adjuvant anthracycline-based chemotherapy in high-risk breast cancer patients
Creators: name: Maj-Britt Jensen
name: Anne-Vibeke Lænkholm
name: Balslev, Eva
name: Buckingham, Wesley
name: Ferree, Sean
name: Glavicic, Vesna
name: Jensen, Jeanette Dupont
name: Knoop, Ann Søegaard
name: Mouridsen, Henning T.
name: Nielsen, Dorte
name: Nielsen, Torsten O.
name: Ejlertsen, Bent
Publisher: name: figshare
Year: 2020
Subjects: subject: Cancer
subject: Medicine
subject: 111203 Cancer Genetics
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: 111205 Chemotherapy

description: The DBCG89D trial randomized high-risk early breast cancer patients to adjuvant CMF (cyclophosphamide, methotrexate and fluorouracil) or CEF (cyclophosphamide, epirubicin and fluorouracil). Prosigna assays were performed by researchers with no access to clinical data. Time to distant recurrence (DR) was the primary endpoint, time to recurrence (TR) and overall survival (OS), secondary. The purpose of the present study was to use DBCG 89D, a symmetrically designed randomized trial of CEF against CMF, to evaluate whether patients with a human epidermal growth factor receptor 2 (Her2)-enriched subtype achieve a significantly better outcome with CEF compared to CMF.<br><b>Study approval and patient consent</b>: The Biomedical Research Ethics of the Danish Capital Region approved the protocol (H-15006199) and granted dispensation from consent.<br><b>Data access</b>: The <b>dataset DBCG89D_Nano.SAS</b> supporting all the figures, tables and supplementary tables in the published article, is not publicly available due to institutional restrictions. The dataset can be made available to qualified researchers through application to the Danish Breast Cancer Cooperative Group. Please contact <b>dbcg.rigshospitalet@regionh.dk</b>. <br><b>Study aims and methodology</b>: The purpose of the present study was to use DBCG 89D, a symmetrically designed randomized trial of CEF against CMF, to evaluate whether patients with a Her2-enriched subtype achieve a significantly better outcome with CEF compared to CMF.Details of DBCG 89D trial have been published previously (<b>https://doi.org/10.1016/j.ejca.2007.01.009</b>). In brief, this was an open-label randomized phase 3 trial. After completion of surgery, consented patients were randomized in a factorial study design to CMF, CMF plus pamidronate, CEF, or CEF plus pamidronate. Patients with completely resected unilateral invasive early-stage breast cancer were eligible if they were either I) premenopausal patients with node-negative tumors with grade II-III malignancies, II) premenopausal patients with node-positive and hormone receptor-negative tumors, or III) postmenopausal patients with node-positive and hormone receptor-negative tumors. Formalin-fixed, paraffin-embedded blocks from primary excisional surgical specimens were recollected, and NanoString-based PAM50 testing using the Prosigna methodology was performed to determine intrinsic subtype and risk of recurrence (ROR) score. Among the 980 Danish patients enrolled, Prosigna results were obtained in 686. Therefore, RNA extraction and the Prosigna assay were performed on a total of 686 patients. Please refer to the published article for more details on the methodology and statistical analysis.<br><b>Data supporting the figures, tables and supplementary tables in the published article:</b> Dataset <b>DBCG89D_Nano.SAS</b> is in .<b>SAS file</b> format and supports figures 1-5, tables 1 and 2, and supplementary table 1 of the published article. The dataset contains primary clinical outcome data for DBCG 89D.<br><b>Software needed to access data</b>: The SAS software is required to access the dataset DBCG89D_Nano.SAS.<br><br><br>