Alberta Health Services Adds PERJETA®-HERCEPTIN® Combo Pack for Treatment of HER2-Positive Metastatic Breast Cancer to the

Alberta Health Services Adds PERJETA®-HERCEPTIN® Combo Pack for Treatment of 
HER2-Positive Metastatic Breast Cancer to the Provincial Formulary 
MISSISSAUGA, ON, Jan. 17, 2014 /CNW/ - People with HER2-positive metastatic 
breast cancer in Alberta will now be able to access a new treatment option 
through the Outpatient Cancer Drug Benefit Program of Alberta Health Services 
(AHS).  Pertuzumab (PERJETA) and trastuzumab (HERCEPTIN) have been approved 
for use in combination with a taxane for the treatment of patients with HER2 
positive unresectable locally recurrent or metastatic breast cancer who have 
not received prior anti-HER2 therapy or chemotherapy for metastatic disease or 
who have not relapsed within six months of receiving trastuzumab in the 
adjuvant setting.(1) 
"The addition of the PERJETA-HERCPETIN Combo Pack to the Alberta formulary 
provides an important option in a HER2-positive metastatic breast cancer 
patient's fight against the disease, and we applaud Alberta Health Services 
for taking this important step," said Mr. Ronnie Miller, president and CEO, 
Roche Canada. "At Roche Canada, we are committed to continually improving 
breast cancer treatments through innovative research and development, and we 
are pleased that patients in Alberta now have another treatment choice 
available to them." 
In Canada, breast cancer is the most commonly diagnosed cancer in women.(2)  
It accounts for 26 per cent of all cancer cases, making it the second leading 
cause of death in women.(2 )On average, 2,100 women in Alberta are diagnosed 
with breast cancer every year.(3) 
Metastatic (also known as advanced, secondary or stage IV) breast cancer, the 
spread of cancer cells from the original site where the cancer first formed to 
other parts of the body, is associated with increased severity and is largely 
incurable.(4,5 )The median survival for a woman with this form of breast 
cancer is two years.(4) 
Women with HER2-positive breast cancer test positive for a protein called 
human epidermal growth factor receptor (HER2).(6)  This protein is found in 
high quantities on the outside of HER2-positive breast cancer cells.  
HER2-positive breast cancer represents approximately 10 to 20 per cent of 
human cancers, and without treatment, it is associated with aggressive tumour 
growth and poor clinical outcomes. (5,7,8) Approximately 5,000 women in Canada 
are living with this disease.(9) 
To-date, British Columbia, Ontario, Saskatchewan and Alberta have funded the 
PERJETA (pertuzumab), in combination with the current standard of care, 
HERCEPTIN® (trastuzumab) and docetaxel chemotherapy, is approved by Health 
Canada for the treatment of patients with HER2-positive metastatic breast 
cancer who have not received prior anti-HER2 therapy or chemotherapy for 
metastatic disease.(10) 
The Health Canada approval of PERJETA is largely based on the phase III 
CLEOPATRA trial.  In the trial, people who received a combination of PERJETA, 
HERCEPTIN and docetaxel chemotherapy, lived a median 6.1 months longer without 
their cancer getting worse (progression-free survival) compared with the 
standard of care, HERCEPTIN plus docetaxel chemotherapy, alone (median PFS 
18.5 versus 12.4 months ; HR=0.62; p<0.0001).(9,11  )Further, the combination 
of PERJETA, HERCEPTIN and docetaxel chemotherapy significantly extended the 
lives of people with previously untreated HER2-positive metastatic breast 
cancer (overall survival) compared to HERCEPTIN, docetaxel chemotherapy and 
placebo.  The risk of death was reduced by 34 per cent for people on the 
PERJETA arm of the study, compared to those who received HERCEPTIN and 
docetaxel chemotherapy alone (HR=0.66; p=0.0008).(12)  At the time of the data 
analysis, median overall survival had not yet been reached because more than 
half of the patients receiving the PERJETA combination were still alive.(11) 
The combination of PERJETA, HERCEPTIN and chemotherapy is thought to provide a 
more comprehensive blockade of HER signaling pathways. 
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused 
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche 
is the world's largest biotech company, with truly differentiated medicines in 
oncology, infectious diseases, inflammation, metabolism and neuroscience. 
Roche is also the world leader in in vitro diagnostics and tissue-based cancer 
diagnostics, and a frontrunner in diabetes management. Roche's personalized 
healthcare strategy aims at providing medicines and diagnostic tools that 
enable tangible improvements in the health, quality of life and survival of 
patients. In 2012 Roche had over 82,000 employees worldwide and invested over 
8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss 
francs. Genentech, in the United States, is a wholly owned member of the Roche 
Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For 
more information, please visit 
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(1) Alberta Health Services.  
(Accessed January 7, 2014)
(2) Canadian Cancer Society.
n=on (Accessed October 29, 2013)
(3) Canadian Breast Cancer Foundation.
tCancerinCanada.aspx (Accessed January 7, 2014)
(4) Canadian Breast Cancer Network. (Accessed 
March 19, 2013)
(5) BC Cancer Agency. (Accessed March 19, 2013)
(6) Chia et al. Human Epidermal Growth Factor Receptor 2 Overexpression As a 
Prognostic Factor in a Large Tissue Microarray Series of Node-Negative Breast 
Cancers, Journal Of Clinical Oncology. 2008;26:5697-5700
(7) Ross et al. The HER-2 Receptor and Breast Cancer: Ten Years of Targeted 
Anti-HER-2 Therapy and Personalized Medicine, The Oncologist. 2009;14:320-368
(8) Wolff et al. American Society of Clinical Oncology/College of American 
Pathologists Guideline, Recommendations for Human Epidermal Growth Factor 
Receptor 2 Testing in Breast Cancer, Arch Patho Lab Med 2007;101:18-43
(9) Tell Her 2 (Accessed October 29, 2013)
(10) PERJETA™ Product Monograph.  April 12, 2013.  Hoffmann-La Roche Limited.
(11) Baselga J, Cortes J, Sung-Bae K, et al. Pertuzumab plus trastuzumab plus 
docetaxel for metastatic breast cancer. N Engl J Med. 2012; 366:109-110.
(12) Swain S, et al. Confirmatory overall survival analysis of CLEOPATRA: A 
randomized, double-blind, placebo-controlled Phase III study with pertuzumab, 
trastuzumab, and docetaxel in patients with HER2-positive first-line 
metastatic breast cancer. Poster presented at the 2012 CTRC-AARC San Antonio 
Breast Cancer Symposium. Abstract # P5-18-26.

SOURCE  Roche Canada 
Laura Pagnotta Manager, Corporate Relations Roche Canada 905-542-5853 
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