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FGFR and ligands thereof as biomarkers for breast cancer in HR positive subjects

A biomarker, FGFR1 technology, applied in biochemical equipment and methods, microbial measurement/testing, instruments, etc., can solve the problems of tumor proliferation and poor prognosis

Inactive Publication Date: 2013-12-04
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

FGFR1 amplification is uncommon in HER2-amplified breast cancers, as described by Elsheikh S, Green AR, Lambros MB, Turner NC, Grainge MJ et al. in the publication Breast Cancer Res9, R23 (2007), suggesting that HER2 and FGFR1 Amplification of β may be an alternative and mutually exclusive mechanism to activate similar downstream pathways that lead to tumor proliferation and poor prognosis

Method used

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  • FGFR and ligands thereof as biomarkers for breast cancer in HR positive subjects
  • FGFR and ligands thereof as biomarkers for breast cancer in HR positive subjects
  • FGFR and ligands thereof as biomarkers for breast cancer in HR positive subjects

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A clinical study testing the efficacy of dovitinib in FGFR1-amplified and non-amplified metastatic breast cancer

[0038] A multicenter, open-label, phase 2 trial of dovitinib was completed to evaluate the clinical activity of dovitinib and test its clinical efficacy in FGFR1-amplified and non-amplified metastatic breast cancer. The efficacy and safety of dovitinib were studied in 4 groups of patients with metastatic breast cancer: (Group 1: FGFR1+, HR+), (Group 2: FGFR1+, HR-), (Group 3: FGFR1-, HR+), (Group 4: FGFR1-, HR-). Patient selection was done based on FISH / CISH for FGFR1 (truncated ≥6 gene copies). Dovitinib (500 mg) was administered once daily based on a 5-day on / 2-day off regimen. The primary endpoint was RECIST best overall response rate (in pts) with detectable disease at each external radiology review.

[0039] standard constrain

[0040] 1. Patients with histologically confirmed breast cancer and a clinical diagnosis of IBC based on the appearance of...

Embodiment 2

[0064] Example 2: Clinical Study Testing the Efficacy of an FGFR1 Inhibitor (Dovitinib) in FGFR1 Amplified Breast Cancer Patients

[0065] After analyzing the dovitinib clinical study results from patient groups 1, 3, and 4, an exploratory analysis was also performed to further evaluate the clinical response in patients with tumors harboring other gene amplifications. Amplification of FGF ligands (FGF3, FGF4, FGF19) and FGFR2 gene amplification were also completed according to the previously defined protocol. The protocol describes a copy number analysis method for the FGFR1 and FGF3 genes using ABI's predesigned TaqMan TM Copy number determination.

[0066] Method summary

[0067] for FGFR1 and FGF3 Copy number assays were purchased from Applied Biosystems and compared with Copy number reference assays were run together in a duplex real-time polymerase chain reaction (PCR). A copy number assay detects the target gene of interest (in this case FGFR1 or FGF3), and a refe...

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Abstract

The present invention describes methods for diagnosing, treating and determining the prognosis of breast cancer HR+ patient, the methods including detecting the amplification of one or more biomarkers comprising a FGFR ligand such as FGF3, FGF4, FGF19, and / or a FGFR, such as for example FGFR1 in a subject; determining an FGFR1 inhibitor for treating the subject based on the amplification of the one or more biomarkers in the subject; administering to the subject in need thereof the FGFR1 inhibitor and using the one or more biomarkers to indicate prognosis of the subject treated with the FGFR1 inhibitor.

Description

technical field [0001] The present invention relates to the use of biomarkers to diagnose and determine the prognosis of cancer patients. The present invention is particularly directed to the diagnosis, treatment and determination of the prognosis of breast cancer patients with biomarkers based on specific fibroblast growth factor (FGF) ligand loci, such as FGF3, FGF4 and FGF19 and FGF3 with FGF4, FGF19 combination, and a specific fibroblast growth factor receptor (FGFR), FGFR1. Background of the invention [0002] Therapeutic options for breast cancer treatment include surgery, radiation therapy, endocrine therapy, and cytotoxic chemotherapy. Limited attempts to use molecular markers that can provide prognostic information and / or predict treatment outcome have recently been published. [0003] US Patent Application Publication No. 2007 / 0218512A1 discloses biomarkers based on the specific human matrix metalloproteinase (MMP) MMP-26 for the diagnosis and prognosis of breast...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68
CPCC12Q1/6886C12Q2600/158C12Q2600/106C12Q2600/118G01N33/57415G01N33/6893
Inventor H·A·R·加德纳M·石A·约文
Owner NOVARTIS AG
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