Anti-ERBB2 antibody adjuvant therapy

• US 8,591,897 B2
• Filed: 04/06/2006
• Issued: 11/26/2013
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: Genentech, Inc. (Roche Holding AG)
• Original Assignee: Genentech, Inc. (Roche Holding AG)
• Inventors: Bryant, John L.
• Primary Examiner(s): Yu, Misook
• Assistant Examiner(s): HOLLERAN, ANNE L
• Application Number:
  US11/400,638
• Publication Number:
  US 20060275305A1
• Time in Patent Office: 2,791 Days
• Field of Search: 424/130.1, 424/133.1, 424/134.1, 424/138.1, 424/141.1, 424/142.1, 424/143.1, 424/155.1, 424/156.1, 424/174.1
• US Class Current: 424/143.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 39/39558 against tumor tissues, cells, antigens
• CPC Class Codes: A61K 47/6803 Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/14 for lactation disorders, e.g. galactorrhoea
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/32 against translation products of oncogenes
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The present application describes adjuvant therapy of nonmetastatic breast cancer using HERCEPTIN®.

Claims

1. A method of adjuvant therapy comprising administering to a human subject with nonmetastatic HER2 positive breast cancer, following definitive surgery, anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and trastuzumab or an antibody that blocks binding of trastuzumab to HER2.

2. The method of claim 1, wherein the taxoid is paclitaxel or docetaxel.

3. The method of claim 2, wherein trastuzumab is administered.

4. The method of claim 3, wherein trastuzumab is administered at an initial dose or 4 mg/kg, followed by subsequent weekly doses of 2 mg/kg.

5. The method of claim 1, wherein the subject has a high risk of cancer recurrence.

6. The method of claim 5 wherein the subject is less than about 50 years old.

7. The method of claim 5 wherein the subject had a tumor greater than 2 centimeters in diameter.

8. The method of claim 5 wherein the cancer is lymph node-positive.

9. The method of claim 8 wherein the subject had 4-9 involved lymph nodes.

10. The method of claim 8 wherein the subject had 10 or more involved lymph nodes.

11. The method of claim 5 wherein the subject'"'"'s cancer was estrogen receptor (ER) negative.

12. The method of claim 5 wherein the subject'"'"'s cancer was progesterone receptor (PG) negative.

13. The method of claim 1, wherein the antibody is an intact, naked antibody.