An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.
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- STATUS
- Recruiting
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- participants needed
- 138
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- sponsor
- Fudan University
Summary
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.
Description
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment vs. traditional chemotherapy in patients with unresectable locally advanced or metastatic triple negative breast cancer. The specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype staining.These tests would be done on their rebiopsy tumor specimen. Specifically, as to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each TNBC subtype by applying an integrative analysis combining somatic mutation, copy number aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and FUSCC private TNBC database.
Details
| Condition | TNBC - Triple-Negative Breast Cancer |
|---|---|
| Age | 18-70 years |
| Treatment | A1: Pyrotinib with Capecitabine, A2: nab-paclitaxel, B1: everolimus with nab-paclitaxel, B2: nab-paclitaxel, C1: PD-1 with nab-paclitaxel and famitinib, C2: nab-paclitaxel, D1: VEGFR and nab-paclitaxel, D2: nab-paclitaxel, E1: Everolimus with nab-paclitaxel, E2: nab-paclitaxel |
| Clinical Study Identifier | NCT04395989 |
| Sponsor | Fudan University |
| Last Modified on | 19 February 2024 |
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