Herceptin(R) Helps Eradicate HER2-Positive Breast Tumours When Given Before Surgery

BERLIN - European Breast Cancer Conference (EBCC), April 18
(ots/PRNewswire) --

- For Non-UK and Non-US Media Only

- Herceptin Offers Women With HER2-Positive Breast Cancer the
Best Chance of a Cure

New data presented today as part of a late breaking plenary
session at EBCC in Berlin showed that Herceptin (trastuzumab) in
combination with standard chemotherapy prior to breast cancer surgery
(neoadjuvant therapy) completely eradicates the tumours in 45.5% of
women with HER2-positive early breast cancer. This is an impressive
finding since the proportion of women achieving total tumor
eradication with standard chemotherapy alone is less than 30%.(1)
These important results from the GeparQuattro study highlight the
efficacy of early treatment of HER2-positive breast cancer, raising
the prospect of cure.

"Herceptin delivered on its promise of high tumour eradication
when given to women with this aggressive form of breast cancer before
their surgery", said investigator Prof. Dr. von Minckwitz, University
Women's Hospital, Frankfurt, Germany and Managing Director of the
German Breast Group. "The GeparQuattro study is the largest
neoadjuvant clinical trial in women with HER2-positive breast cancer
and shows that Herceptin offers real hope for women with early breast
cancer."

The GeparQuattro results are consistent with other Herceptin
neoadjuvant studies, such as NOAH (NeOAdjuvant Herceptin, including
228 evaluable HER2-positive patients)(2) and TECHNO
(Taxol-Epirubicin-Cyclophosphamid-Herceptin Neoadjuvant), reinforcing
the strong evidence for the benefits associated with Herceptin in the
early stages of HER2-positive breast cancer.

"It is very reassuring to see that the GeparQuattro study
confirmed the significant benefits observed with Herceptin in other
neoadjuvant studies in HER2-positive breast cancer", commented Prof.
Dr. Untch, Helios Clinics, Berlin, Germany, who presented the study
findings. "Herceptin makes women with this aggressive type of breast
cancer feel more confident about their future."

GeparQuattro and NOAH studied Herceptin in combination with
different chemotherapy regimens and showed equally good efficacy
results, indicating that Herceptin can be combined successfully with
different chemotherapies. Measuring the efficacy of Herceptin in
these studies was based on the disappearance of tumour cells in the
breast and in the lymph nodes - a therapeutic success measure known
as complete pathological response, which is a strong predictor for
long-term survival.(3),(4)

HER2-positive breast cancer is diagnosed in approximately 20-30%
of all breast cancer cases.(5) It demands special attention because
the tumours are typically fast-growing, and there is a high
likelihood of the cancer coming back. Pre-surgery therapy is
administered to women to help make large (>2cm) tumours shrink
enabling them to become operable and improve treatment outcomes.

Notes to Editors:

About the GeparQuattro study

GeparQuattro is a study conducted by the AGO and GBG study
groups. It is a randomized phase III study that enrolled 1510
patients - 453 of the patients had HER2-positive disease. Patients
with HER2-positive breast cancer received four cycles of epirubicin
plus cyclophosphamide plus Herceptin. Patients then received one of
three treatment options: either four cycles of docetaxel plus
Herceptin, docetaxel plus Xeloda plus Herceptin concomitantly, or
docetaxel plus Herceptin followed by Xeloda plus Herceptin.
HER2-negative patients received the same chemotherapy regimen without
adding Herceptin. The primary objective of the study was to assess
the efficacy of different chemotherapy regimens. One of the study
endpoints of GeparQuattro was pathological complete response rate
(pCR) including in situ pathological response rate in patients with
HER2-negative and HER2-positive disease. There were no significant
cardiac events observed in the study.

About breast cancer

Breast cancer is the most common cancer among women worldwide.(6)
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.(7)

In HER2-positive breast cancer, increased quantities of the HER2
protein are present on the surface of the tumour cells. This is known
as 'HER2-positivity.' High levels of HER2 are present in a
particularly aggressive form of the disease which responds poorly to
chemotherapy. Research shows that HER2-positivity affects
approximately 20-30 percent of women with breast cancer.

About Herceptin (trastuzumab)

Herceptin is a humanised antibody, designed to target and block
the function of HER2, a protein produced by a specific gene with
cancer-causing potential. It has demonstrated efficacy in treating
both early and advanced (metastatic) breast cancer. Given on its own
as monotherapy as well as in combination with or following standard
chemotherapy, Herceptin has been shown to improve response rates,
disease-free survival and overall survival while maintaining quality
of life in women with HER2-positive breast cancer.

Herceptin received approval for use in the European Union for
advanced (metastatic) HER2-positive breast cancer in 2000, and for
early HER2-positive breast cancer in 2006. In the advanced setting,
Herceptin is now approved for use as a first-line therapy in
combination with paclitaxel where anthracyclines are unsuitable, as
first-line therapy in combination with docetaxel, and as a single
agent in third-line therapy. It is also approved for use in
combination with an aromatase inhibitor for the treatment of
post-menopausal patients with HER2 and hormone receptor co-positive
metastatic breast cancer. In the early setting, Herceptin is approved
for use following standard (adjuvant) chemotherapy.

Herceptin is marketed in the United States by Genentech, in Japan
by Chugai and internationally by Roche. Since 1998, Herceptin has
been used to treat more than 450,000 HER2-positive breast cancer
patients worldwide.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, and is a market
leader in virology. It is also active in other major therapeutic
areas such as autoimmune diseases, inflammatory and metabolic
disorders and diseases of the central nervous system. In 2007 sales
by the Pharmaceuticals Division totalled 36.8 billion Swiss francs,
and the Diagnostics Division posted sales of 9.3 billion francs.
Roche has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai, and invested over 8 billion Swiss francs in R&D in 2007.
Worldwide, the Group employs about 79,000 people. Additional
information is available on the Internet at http://www.roche.com.

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(1) Sachelarie I, et al. Primary systemic therapy of breast
cancer. The Oncologist. 2006;11:574-589

(2) Gianni L, et al., Neoadjuvant trastuzumab in locally advanced
breast cancer (NOAH):antitumor and safety analysis. Abstract # 532.
American Society of Clinical Oncology Annual Meeting 2007

(3) Rastogi et al. Preoperative chemotherapy: updates of National
Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J
Clin Oncol. 2008 Feb 10;26(5):778-85

(4) Kaufmann, von Minckwitz. Preoperative (neoadjuvant) systemic
treatment of breast cancer. Breast. 2005 Dec;14(6):576-81

(5) Harries M, Smith I. The development and clinical use of
trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002

(6) World Health Organization,
http://www.who.int/cancer/detection/breastcancer/en/

(7) Cancer Incidence, Mortality and Prevalence Worldwide. IARC
CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: Corinne Fründt, F.
Hoffmann-La Roche Ltd, Mobile: +41-(0)79-5937216,
corinne.fruendt@roche.com. Patricia Dessert, Ketchum, Mobile :
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