Femara Helps More Women Live Breast Cancer-Free
Wednesday December 28, 7:02 pm ET
Study Proves Most Benefit in Women at High-Risk

FRIMLEY, England, December 29 /PRNewswire-FirstCall/ -- A major trial published today in the New England Journal of Medicine (NEJM)(1) showed that FemaraŪ (letrozole) demonstrated a significant advantage in disease-free survival* versus tamoxifen when used after surgery (adjuvant) in postmenopausal women with hormone receptor-positive early breast cancer. The results were particularly impressive for women at higher risk - with around one third less chance of disease returning in women in this group taking Femara, compared with those taking 'gold standard' tamoxifen. Because of the successful results of the study the MHRA has now approved Femara, three months earlier than expected, for the adjuvant (post surgery) treatment of early breast cancer.

"These results are fantastic news and give hope to women with breast cancer - especially those at high risk of their cancer recurring" said Nigel Bundred, Professor in Surgical Oncology, Wythenshawe Hospital, Manchester. "They show that Femara is more effective than tamoxifen when given to women after surgery and offers even greater advantages to these particularly vulnerable women."

Liz Caroll, Head of Clinical Services at Breast Cancer Care commented: "These results further suggest the benefits of using aromatase inhibitors over tamoxifen in treating early invasive breast cancer and indicate that many more lives could be saved. Many women, like those we support, with breast cancer will welcome the news that they might benefit from this new treatment option, as will the healthcare professionals treating them."

The new trial showed a 29% reduction in recurrence with Femara, compared with tamoxifen, for those women with breast cancer that had already spread to lymph nodes (node-positive early breast cancer). These patients are at the highest risk of breast cancer recurrence and are more likely to develop distant metastases (secondary tumours), increasing their risk of dying. A 28% reduction in risk of recurrence with Femara over and above the benefit seen with tamoxifen, was also seen in those women who had received chemotherapy. (Chemotherapy use indicates that these women were considered to be in a high-risk group).

In the same trial, in all women taking Femara, there was a 27% reduction in the risk of cancer spreading to other parts of the body (distant metastases) and a significant reduction (19%) in the risk of breast cancer returning when compared with those taking tamoxifen.

The data comes from the Breast International Group (BIG) 1-98 trial - one of the largest ongoing studies in this setting. BIG 1-98 is a head-to-head comparison of Femara with tamoxifen involving more than 8,000 women. This independent, international study was conducted by the International Breast Cancer Study Group (IBCSG).

Unlike some other treatments, aromatase inhibitors (AIs) are effective in all types of hormone receptor-positive breast cancer - representing around 80% of all breast cancers. With its recent license, Femara is now the only Aromatase inhibitor (AI) licensed across the entire breast cancer treatment spectrum - before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer.

BIG 1-98 Trial Details

This independent, Phase III, international randomised, double-blind, controlled clinical trial enrolled more than 8,000 postmenopausal women with early breast cancer in 29 countries. The median follow-up time was 26 months. The study was supported by Novartis.

BIG 1-98 is the only clinical trial designed to incorporate both a head-to-head comparison of Femara with tamoxifen during the first five years following breast cancer surgery and a sequencing of both agents to determine the most effective approach to minimise the risk of recurrence. In summary the trial divided into the following four arms:

- Five years of Femara
- Five years of tamoxifen
- Two years of Femara followed by three of tamoxifen
- Two years of tamoxifen followed by three years of Femara.
* Disease-free survival (DFS), the primary efficacy endpoint in this study, is defined as the absence of invasive loco-regional recurrence, distant metastasis, invasive contralateral breast cancer, a second non-breast primary tumour, or death from any cause.

The results published in the NEJM (29 December 2005) are from the Femara and tamoxifen only (monotherapy) arms. Further results from the ongoing arms of the study, due in 2008, are expected to determine which treatment is more effective, monotherapy or sequential therapy, and which sequence is more effective.

UK Trial Centres

Over 400 women are taking part in the trial throughout 11 trial centres in the UK. These trial centres include:

Hospital Location

Bournemouth Hospital Bournemouth
North Middlesex Hospital London
Royal Marsden London
Withington Hospital Manchester
Christie Hospital Manchester
Ninewells Hospital Dundee
Leeds General Infirmary Leeds
St James University Hospital Leeds
Harrogate District Hospital Harrogate
Weston Park Hospital Sheffield
Huddersfield Royal Infirmary Huddersfield
Airedale General Hospital Keighley
Castle Hill Hospital Hull

About Femara
Femara is a once-a-day oral aromatase inhibitor currently indicated in the UK for:

- Adjuvant (post-surgery) treatment of postmenopausal women with hormone receptor-positive invasive early breast cancer

- The treatment of early invasive breast cancer in postmenopausal women who have completed prior standard adjuvant tamoxifen therapy

- Newly diagnosed postmenopausal women with advanced breast cancer

- Postmenopausal women with advanced breast cancer in whom tamoxifen, or other anti-oestrogen therapy, has failed

- Neoadjuvant (pre-operative) therapy in postmenopausal women with localised hormone receptor-positive breast cancer, to allow subsequent breast-conserving surgery in women not originally considered to be candidates for breast-conserving therapy

About Novartis

Novartis AG (NYSE: NVS - News) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81,400 people and operate in over 140 countries around the world.


1. Thurlimann B et al. Adjuvant letrozole reduces the risk of relapse in postmenopausal women with receptor positive early breast cancer compared with tamoxifen: first results of the BIG 1-98 trial. N Engl J Med, December 2005.