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Treatment of metastatic breast cancer

a breast cancer and metastatic technology, applied in the field of metastatic breast cancer treatment, can solve the problems of short-lived rare complete responses, reduced tumor proliferation and survival, etc., and achieve the effect of prolonging the survival of human patients, prolonging progression free survival (pfs) or overall survival

Inactive Publication Date: 2014-02-13
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a combination of three drugs, pertuzumab, trastuzumab, and docetaxel, that work together to improve treatment for breast cancer. The combination can increase the effectiveness of the drugs and help to extend the life of patients with breast cancer. This is especially true for progression-free survival and overall survival.

Problems solved by technology

Pertuzumab blockade of the formation of HER2-HER3 heterodimers in tumor cells has been demonstrated to inhibit critical cell signaling, which results in reduced tumor proliferation and survival (Agus et al.
Although chemotherapy agents, such as anthracyclines, taxanes, alkylating agents, and / or vinca alkaloids, used as single agents, have produced important results in extending the survival of patients with metastatic breast cancer, the rare complete responses are short-lived, and usually the disease continues to progress.

Method used

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  • Treatment of metastatic breast cancer
  • Treatment of metastatic breast cancer
  • Treatment of metastatic breast cancer

Examples

Experimental program
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Effect test

example 1

Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab+Trastuzumab+Docetaxel Treatment of Previously Untreated Metastatic Breast Cancer

[0358]Primary Objectives

[0359]The primary objective of this study is to compare progression-free survival (PFS) based on tumor assessments by an independent review facility (IRF) between patients in two treatment arms:

[0360]placebo+trastuzumab+docetaxel vs. pertuzumab+trastuzumab+docetaxel.

[0361]Secondary Objectives[0362]To compare overall survival (OS) between the two arms[0363]To compare PFS between the two treatment arms based upon investigator assessment of progression[0364]To compare the overall objective response rate between the two treatment arms[0365]To compare the duration of objective response between the two treatment arms[0366]To compare the safety profile between the two treatment arms[0367]To compare time to symptom progression, as assessed by the FACT Trial Outcome Index-Physical Functional Breast (TOI-PFB)[0368]To...

example 2

Pharmacokinetic, Drug-Drug Interaction, and QTc Interval Substudy

[0508]This substudy has two main goals: (1) to describe the potential effects of pertuzumab on the QTc interval, and (2) to evaluate the pharmacokinetic profile of pertuzumab in the presence of trastuzumab and docetaxel and to describe any drug-drug interactions that might be observed when all three drugs are co-administered.

[0509]QTC Prolongation

[0510]Drug-induced prolongation of the QT / corrected QT (QTc) interval resulting in increased susceptibility to cardiac arrhythmia is a recognized complication of many drugs across a wide therapeutic spectrum (Morissette et al. Can J Cardiol 2005; 21:857-64). Prolongation of the QT / QTc interval, which is usually asymptomatic, may be manifested by syncope resulting from cardiac arrhythmias such as torsades de pointes (TdP), ventricular arrhythmia, and sudden cardiac death (Morganroth rnst Schering Res Found Workshop 2007; 59:171-84).

[0511]Measurement of QT is made by an electroc...

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Abstract

The present invention concerns treatment of previously untreated HER2-positive metastatic breast cancer with a combination of a growth inhibitory HER2 antibody, a HER2 dimerization inhibitor antibody and a taxane. In particular, the invention concerns the treatment of HER2-positive metastatic breast cancer in patients who did not receive prior chemotherapy or biologic therapy with a HER2 antibody binding essentially to epitope 2C4, a HER2 antibody binding essentially to epitope 4D5, and a taxane. The invention further comprises extending survival of such patients by the combination therapy of the present invention. In a preferred embodiment, the treatment involves administration of trastuzumab, pertuzumab and docetaxel.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 12 / 484,440, filed Jun. 15, 2009, which claims priority under 35 U.S.C. Section 119(e) and the benefit of U.S. Provisional Application Ser. No. 61 / 061,962, filed Jun. 16, 2008, the entire disclosures of which are incorporated herein by reference.INCORPORATION OF SEQUENCE LISTING[0002]This application includes a Sequence Listing submitted via EFS-Web on Aug. 25, 2009, as a computer-readable form file entitled “GNE-0318USrevised.txt” (32 KB) dated Aug. 12, 2009. Which is hereby incorporated herein by reference it its entirety.FIELD OF THE INVENTION[0003]The present invention concerns treatment of previously untreated HER2-positive metastatic breast cancer with a combination of a growth inhibitory HER2 antibody, a HER2 dimerization inhibitor antibody and a taxane. In particular, the invention concerns the treatment of HER2-positive metastatic breast cancer in patients who ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/395A61K45/06C07K16/28A61K31/337
CPCA61K39/3955C07K16/2863A61K45/06A61K31/337A61K39/39558C07K16/32A61P35/00A61P35/04A61K2300/00A61K2039/507C07K16/3015C07K2317/24C07K2317/73C07K2317/21C07K2317/76
Inventor PATON, VIRGINIABLACKWOOD CHIRCHIR, ANNEKLEIN, PAM
Owner GENENTECH INC
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