Blood plasma biomarkers for bevacizumab combination therapies for treatment of breast cancer

A biomarker, breast cancer technology, used in drug combination, biomaterial analysis, antitumor drugs, etc.

Inactive Publication Date: 2015-02-18
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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  • Blood plasma biomarkers for bevacizumab combination therapies for treatment of breast cancer
  • Blood plasma biomarkers for bevacizumab combination therapies for treatment of breast cancer
  • Blood plasma biomarkers for bevacizumab combination therapies for treatment of breast cancer

Examples

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Embodiment 1

[0121] Example 1: Bevacizumab in Combination with Trastuzumab / Docetaxel as First-Line Therapy for Patients with HER2-Positive Locally Recurrent or Metastatic Breast Cancer Compared to Trastuzumab / Docetaxel Alone of patients – the AVEREL study

[0122] The primary objective of the clinical trial disclosed herein was to compare patients randomized to the combination of bevacizumab and trastuzumab / docetaxel with patients randomized to trastuzumab / docetaxel alone Progression-free survival (PFS) in . Secondary objectives were to assess overall survival (OS); best overall response (OR); duration of response (DR); time to treatment failure (TTF); combination bevacizumab with trastuzumab and docetaxel safety and tolerability; and ultimately quality of life.

[0123] Specifically, the study described herein determined (1) the combination of trastuzumab (8 mg / kg loading dose, followed by 6 mg / kg every 3 weeks until disease progression) + docetaxel (100 mg / m 2 , every 3 weeks for a mi...

Embodiment 2

[0216] Example 2: Exploratory Biomarker Analysis in the AVEREL Study

[0217] Patients and Immunochemical Methods

[0218] Baseline plasma samples from 162 patients in this trial were available for analysis.

[0219] plasma analysis

[0220] Blood samples for biomarker discovery and validation were collected from consenting patients in Study BO20231. Blood samples (approximately 20 mL total) were collected at baseline (after randomization but before the first administration of study medication) and at disease progression.

[0221] A total of 4.9 mL of blood was drawn into one S- (EDTA) tube. Immediately thereafter they were mixed by gentle inversion of the tubes and centrifuged at approximately 1500 g in a centrifuge within 30 minutes (10 minutes at room temperature). Immediately thereafter, the plasma supernatant was aliquoted in a clear polypropylene 5 mL transfer tube. Thereafter, the plasma was equally divided into 2 plastic preservation tubes (approximately 1.25 ml...

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Abstract

The present invention provides methods for improving the treatment effect of a chemotherapy regimen of a patient suffering from HER2 positive breast cancer, in particular locally recurrent or metastatic HER2 positive breast cancer, by adding bevacizumab (Avastin ®) to a chemotherapy regimen by determining the expression level, in particular the blood plasma expression level, of E-selectin, ICAM-1 or VEGFR-3 relative to control levels of patients diagnosed with HER2 positive breast cancer, in particular locally recurrent or metastatic HER2 positive breast cancer.

Description

field of invention [0001] The present invention is directed to methods for identifying which patients diagnosed with breast cancer would benefit most from treatment with anti-cancer therapy comprising an anti-VEGF antibody. Background of the invention [0002] Angiogenesis contributes to benign and malignant diseases such as cancer formation and, especially in cancer, is required for primary tumor growth, invasion and metastasis. In order to grow, tumors must undergo an angiogenic switch. Vascular endothelial growth factor (VEGF) is required to induce this angiogenic switch. VEGF and genes in the VEGF pathway are considered important mediators of cancer progression. The VEGF gene family includes the VEGF gene (also known as VEGFA), homologues of VEGF including placental growth factor (PlGF), VEGFB, VEGFC, VEGFD, VEGF receptors including VEGFR-1 and VEGFR-2 (also known as FLT1 and FLK1 / KDR), VEGF inducers, including hypoxia inducible factors HIF1α, HIF2α, and oxygen sensor...

Claims

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Application Information

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IPC IPC(8): G01N33/574A61K35/00
CPCG01N33/57415G01N2333/475A61P35/00
Inventor U·克劳泽N·穆尔C·帕劳德S·谢勒N·怀尔德
Owner F HOFFMANN LA ROCHE & CO AG
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