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15.12.2007 – 14:02

Roche Pharmaceuticals

Herceptin Improves Survival in Women With Advanced HER2-Positive Breast Cancer Requiring Additional Treatment

San Antonio, Texas (ots/PRNewswire)

- Studies Show Breast Cancer Patients Benefit From Continued Use of Herceptin After Progression of the Disease

Data presented at the 30th Annual San Antonio Breast Cancer Symposium confirm that Herceptin is the standard of care for women with HER2-positive breast cancer across all stages of the disease. The first interim evidence from a randomized phase III trial suggests that Herceptin continues to work in patients requiring an additional line of treatment for their metastatic disease. In addition, a large retrospective analysis showed that use of Herceptin in these women leads to improved survival when given in subsequent lines of treatment.

Unfortunately, for many women with advanced breast cancer their disease continues to spread after their initial treatment and patients are likely to receive several subsequent lines and types of therapy. These studies are important as they address the question of whether continuing Herceptin in additional lines of treatment provides benefit in women with advanced disease.

The study presented by Prof. von Minckwitz and colleagues compared the use of Herceptin plus Xeloda (a standard chemotherapy) with Xeloda alone after previous Herceptin therapy. The results showed that patients who continued to receive Herceptin with the addition of Xeloda achieved a higher response rate (48.9%) than with Xeloda alone (24.6%)(1). In addition, growth of their cancer was prevented for a longer period of time.

"These interim results from our phase III study demonstrate that to continue treatment with trastuzumab and change the chemotherapy regimen after initial progression of the disease provides benefit to women with HER-2 positive metastatic breast cancer", commented Prof. von Minckwitz, Lead Investigator of the study from the German Breast Group.

Professor Jackisch and colleagues showed that in routine clinical practice many women with HER2-positive metastatic breast cancer receive Herceptin in a variety of combinations when additional courses of therapy are required. In their analysis, treatment schedules and outcomes for over 900 women receiving Herceptin were assessed retrospectively over six years. Results show that giving Herceptin in combination with chemotherapy achieves high response rates and prolongs survival in patients who had previously received Herceptin alone or in combination with other therapies as their first line treatment.(2)

"Herceptin is highly effective and well tolerated in the routine clinical management of patients with locally advanced or metastatic HER2-positive breast cancer. It is very reassuring for women that the study data suggest significant benefits in subsequent lines of treatment" said Prof. Jackisch, Department of Obstetrics and Gynecology and Breast Center at Offenbach Clinic, Offenbach, Germany.

The emerging evidence from these new studies and previous data confirm that Herceptin is the standard of care for women with HER2-positive breast cancer, offering the best chance of a cure and helping women live longer.

Notes to editors:

About the von Minckwitz study

This is a phase III trial looking at Herceptin treatment in patients with HER2-positive metastatic breast cancer requiring subsequent lines of treatment. Interim results were presented at SABCS 2007, with final results expected in 2008.

Women with HER2-positive locally advanced or metastatic breast cancer that had received prior Herceptin with or without chemotherapy as first line treatment were randomly assigned to receive Herceptin (6 mg/kg body weight every 3 weeks) with capecitabine (2500 mg/m(squared) on days 1-14, q 21), or capecitabine treatment alone. The primary end point was time to progression. The interim analysis includes 156 patients.

About the Jackisch study

This is a retrospective German observational trial evaluating routine clinical usage of Herceptin in advanced breast cancer from 2001 to 2006.

A total of 910 patients were followed in 142 German centres. The median duration of documented Herceptin therapy was 11.2 months. Additional information on long-term outcomes, progression-free survival and overall survival were collected in a subgroup of 485 patients, in which treatment documentation had been finalized before July 2004. Patients were stratified into three cohorts depending on treatment type:

- Herceptin single-agent therapy: 102 patients (11%)

- Herceptin combined with chemotherapy with or without endocrine therapy: 715 patients (79%)

- Herceptin combined with endocrine therapy only: 93 patients (10%).

The effect of Herceptin treatment in patients requiring subsequent lines of therapy was analysed in 112 patients continuing Herceptin versus 81 patients not receiving Herceptin.

About breast cancer

Breast cancer is the most common cancer among women worldwide.(3) 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.(4)

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 nearly 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, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at

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(1) Von Minckwitz G, et al. Trastuzumab treatment beyond progression in patients with HER2 positive metastatic breast cancer - interim report. Phase III trial. Abstract 4056. SABCS Meeting 2007

(2) Jackisch J, et al. Routine clinical usage of Trastuzumab (Herceptin) in advanced breast cancer in Germany from 2001 to 2006. Abstract 4059. SABCS Meeting 2007

(3) World Health Organization,

(4) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004


For further information please contact: Corinne Fründt, F.
Hoffmann-La Roche Ltd, Mobile: +41(0)79-5937216,; Amanda Sefton, Ketchum, Mobile:

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