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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: 2009-12-24
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method for treating breast cancer using a combination of trastuzumab, pertuzumab, and docetaxel. The method involves administering these antibodies to a patient who has not received prior chemotherapy or biologic therapy. The growth inhibitory antibody targets epitope 2C4, and the HER2 dimerization inhibitor antibody targets epitope 4D5. The HER2 antibodies can be administered as fragments, chimeric humanized or human antibodies, or as naked antibodies. The method results in a synergistic effect and extends survival of the patient. The invention also provides a kit comprising the antibodies and a package insert or label with directions for treating a HER2 positive metastatic breast cancer patient.

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

[0356]Primary Objectives

[0357]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:

[0358]placebo+trastuzumab+docetaxel vs. pertuzumab+trastuzumab+docetaxel.

[0359]Secondary Objectives[0360]To compare overall survival (OS) between the two arms[0361]To compare PFS between the two treatment arms based upon investigator assessment of progression[0362]To compare the overall objective response rate between the two treatment arms[0363]To compare the duration of objective response between the two treatment arms[0364]To compare the safety profile between the two treatment arms[0365]To compare time to symptom progression, as assessed by the FACT Trial Outcome Index-Physical Functional Breast (TOI-PFB)[0366]To...

example 2

Pharmacokinetic, Drug-Drug Interaction, and QTc Interval Substudy

[0506]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.

[0507]OTC Prolongation

[0508]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).

[0509]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]The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 61 / 061,962, filed Jun. 16, 2008, all of which is fully incorporated herein by reference.FIELD OF THE INVENTION[0002]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.BACKGROUND OF TH...

Claims

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Application Information

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