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In the United States breast cancer second leading cause of death for women. 1 “Each year more than one million new cases of breast cancer are diagnosed worldwide and nearly 400,000 people will die of the disease annually.” 13 A malignant (cancerous) tumor of the breast refers to those cells located on the breast dividing faster than normal forming abnormal tissue (tumor). Many factors risk developing breast cancer including hereditary, lack of exercise, excessive alcohol consumption, use of hormone replacement therapy, birth control pills, smoking, and other factors. “Most women diagnosed with breast cancer have no known risk factors”. Breast cancer may spread to other parts of the body (Advanced or metastatic breast cancer) referred to as 'stage IV', including liver, lungs, and bone as serious health concern. 2

Many different types of breast cancers one type is HER2 – positive breast cancer. Normal cell growth is regulated by genes, particularly HER2 (human epidermal growth factor receptor 2 ) gene. HER2 makes a protein tryrosine kinase, a growth factor receptor. 3 HER2 receptor found on the surface of normal cells in the body. (The HER2 gene is found in the DNA of a cell). The HER2 proteins normal function send signals from outside of the cell to the inside of the cell, facilitates normal cell growth and division. 6 When multiple copies of HER2 protein present on the cell surface, cause abnormal cell growth, as a result breast tumors grow faster, and more difficult to treat with chemotherapy and hormone therapy. “An estimated 20 to 25 percent of breast cancers make these extra copies of HER2 gene.” An estimated 20,000 HER2 receptors in a healthy breast cell; “a breast cancer cell could have as many as 1.5 million.” 3 The Multiple HER2 protein is not inherited, but likely related to aging. Researchers have not proven if HER2 caused by any environmental factors. If breast cancer test status is HER2 negative, then the HER2 protein is not causing the cancer to spread rapidly. 4 In the United States, about 40,000 women each year diagnosed with HER2 – positive breast cancer. 3 This type of aggressive breast cancer may be more likely to have a recurrence, despite if the cancer is fortunately cured initially. 6

The American Society of Clinical Oncology (ASCO) recommends women diagnosed with breast cancer, should either have an additional biopsy or examination of the stored cell tissue tumor biopsy, test for HER2 positive or negative status. Depending on the test results, a course of treatment would be recommended by the patient's physician or health advisors. 5 “In addition, the treatment of HER2+ breast cancer is different than the treatment of breast cancer that is not HER2+.” 6

Pertuzumab (previously known as Omnitarg) developed by Genentech biotechnology company (14) , proven to prolong survival time for women with stage three ovarian cancer according to Phase Two Clinical trial data (Presented September 14, 2007 during a scientific session of the fourteenth European Cancer Conference – Barcelona Spain 16) with 130 patients. 15 Pertuzumab added weeks to live for Stage three ovarian cancer patients compared to existing chemotherapy, proved to be unsuccessful, since the disease returned after treatment. 16

In 2008, During the meeting of the American Society of Clinical Oncology in Chicago, presented data from a phase Two Study, regarding Roche Holding AG's (World's biggest biotech company based in Switzerland – Research products and services for early detection, prevention, diagnosis and treatment of diseases 13) Herceptin (Useful to treat early diagnosis of breast cancer and more effective combined with chemotherapy, reducing half the number of recurring cancers 9) combined with Pertuzumab, significantly treated HER2 – positive metastatic breast cancer patients. 7 “But pertuzumab works by preventing the HER2 protein from binding with other cells, a pairing which is thought to play an important role in the growth and spread of cancer (humanized monoclonal antibody – Inhibit the process of HER 12).” 8 The study showed a quarter of the 66 patient tumors disappear or shrink, eight percent of the participants cancers were cured, and twenty-five percent of the patients, cancer did not worsen for at least six months.10 During the Phase Two Study, patients well tolerated the combination of drugs, and none of the participants withdrawn from the trial, related to any adverse side effects. 7 Dr. David Miles oncologist at Mount Vernon Hospital north – west London and Trial investigator of the study said: “The efficacy of the study is impressive considering that this was a treatment regimen containing two antibodies only; one that did not involve any chemotherapy (Known adverse side effects include nausea, vomiting, hair loss, and likely develop infections, bruises or bleed easily 11), and represents significant promise for women with breast cancer in the future.” 10 In the United Kingdom, combination of Herceptin and pertuzumab may be licensed for available use within five years. 8

More effective than the combination of Herceptin and Pertuzumab additional chemotherapy to treat advanced cancer, began to be studied in January 2008, during Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) Phase Three Study (First time metastatic breast cancer patients) underway in 19 countries worldwide. Favorable trial study results may pave the way, new standard treatment care for HER2 – positive metastatic breast cancer patients. 7

References:

1) BREAST CANCER – http://www.mayoclinic.com/health/breast-cancer/DS00328/FLUSHCACHE=0&UPDATEAPP=false

2.) Breast Cancer Basics – http://www.her2breastcancer.co.nz/basics.html

3.) AACR Cancer Concepts HER2 – http://www.aacr.org/home/public–media/for-the-media/fact-sheets/cancer-concepts/her2.aspx

4.) HER2/neu and Diagnosis – http://breastcancer.about.com/od/diagnosis/p/her2_diagnosis.htm

5.) HER2 – Positive Breast Cancer – http://www.her2genes.com/her2genes/her2testing.jsp

6.) HER2 Testing Information – http://www.herceptin.com/herceptin/patient/testing/her2.jsp

7.) Pertuzumab With Herceptin(R) Shows Impressive Results in Women With Advanced HER2 – Positive Breast Cancer – http://www.presseportal.de/pm/24678/1201062/roche_pharmaceuticals/rss

8.) New drug shrinks even the most severe breast cancer tumors – http://www.mailonsunday.co.uk/health/article-1023403/New-drug-shrinks-severe-breast-cancer-tumours.html?ITO=1490

9.) HER2 testing and breast cancer – http://www.cancerbackup.org.uk/Cancertype/Breast/Causesdiagnosis/HER2testing

10.) New drug could fight breast cancer – http://www.channel4.com/news/articles/society/health/new+drug+could+fight+breast+cancer/2267432

11.) Definition of Chemotherapy – http://www.medterms.com/script/main/art.asp?articlekey=2698

12.) Phase 1 Clinical Study of Pertuzumab, a Novel HER Dimerization Inhibitor, in Patients With Advance Cancer – http://jco.ascopubs.org/cgi/content/full/23/11/2534

13.) Investigational cancer drug Pertuzumb shows promising results in advance breast cancer when combined with Herceptin – http://www.roche.com/med-cor-2007-06-04c

14.) Genentech Announces Positive Results From a Randomized Phase 2 Study of Pertuzumab in Combination with Gemcitabine for Advanced Ovarian Cancer – http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/01-04-2007/0004500084&EDATE=

15.) Pertuzumab Boosts Survival in Recurrent Ovarian Cancer Patients –

http://www.biotech weblog.com/50226711/pertuzumab_boosts_survival_in_recurrent_ovarian_cancer_patients.php

16.) Experimental drug pertuzumb boosts survival in recurrent ovarian cancer – http://www.news-medical.net/?id=30499