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Data for: Randomized trial of neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER+/HER2- breast cancer (PREDIX LumB): Primary analysis and development of the CDKPredX metagene predictor

https://doi.org/10.48723/j14a-6r76
The dataset contains whole-exome sequencing (WES) and RNA sequencing (RNA-Seq) FASTQ files derived from tumor tissue samples collected in the PREDIX Lum B clinical trial (prospective randomized phase II, ClinicalTrials.govOpens in a new tab ID: NCT02603679) conducted at three hospitals in Sweden. In total, the dataset includes 166 WES samples and 163 RNA-Seq samples. For WES, matched normal blood samples are also included. Metadata file containing patient anonymized ID, treatment arm, gender, and the corresponding WES and RNA-seq sample anonymized IDs. Files are organized by sequencing type (WES and RNA-Seq), plus a metadata table listing all variables: trial ID, gender, treatment arm, and associated file paths. No specialized software is required to open the FASTQ files or metadata. Downstream analysis requires related bioinformatics tools. The dataset consists of: - 4,974 FASTQ files, compressed as GNU zip files - 3 CSV files - 1 readme file in TXT format The total size of the dataset is approximately 7.6 TB
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The dataset does not contain direct identifiers such as names, social security numbers, or contact details. Each patient is represented by a trial-specific ID. The trial-specific IDs are pseudonymized and cannot be used to identify individual patients. Linkage to individual identities is only possible by the local principal investigator and designated site staff through site-specific keys, which are not shared. The metadata include gender and treatment arm, which are indirect identifiers. The sequencing data (FASTQ files from WES and RNA-Seq) represent molecular profiles, which qualify as sensitive health-related data. Although pseudonymized, genomic data are inherently identifiable and are protected under regulations for genetic and health data.

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