Patients in early-stage HER2-positive breast cancer should remain on Herceptin (trastuzumab) treatment for one year, and not two years or six months, according to a final analysis of the Phase III HERA trial, pharmaceutical company Roche and the Breast International Group announced today.

Experts say that had the trial found six months of Herceptin was better than one year, Swiss pharmaceutical giant, Roche would have lost approximately $1.5 billion in revenue from this medication.

Herceptin is a breast cancer blockbuster medication with sales last year of $5.5 billion. Approximately one quarter of patients with breast cancer tumors which generate HER2, a protein which makes the disease much more aggressive, are treated with Herceptin.

The latest data from the Phase III HERA trial demonstrated that two years of treatment on Herceptin made no difference to patients' disease-free survival times - how long women lived without the cancer coming back.

After being followed up for an average of eight years, the trial showed that disease-free survival improvements and overall survival for those on Herceptin was statistically significant when compared to patients on just observation. Roche added that "there were no safety findings in the trial".

Hal Barron, M.D., Roche's Chief Medical Officer and Head of Global Product Development, said:

"Herceptin has changed the lives of many people with HER2-positive early breast cancer by increasing their chance of cure. HERA is one of the largest and longest-running breast cancer trials and demonstrates our commitment to people with this aggressive disease. These results answer an important question and support current medical practice, where Herceptin treatment for one year is recommended and approved for people with early-stage HER2-positive breast cancer."

Dr Martine Piccart, Chair of Breast International Group, said:

"It's essential that our clinical trials help us understand just how long patients need to receive a particular treatment. These results give us both the evidence and the reassurance that it's not necessary to give patients with early-stage HER2-positive breast cancer Herceptin for more than one year."

Data on the HERA trial was presented today at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria, by Richard D. Gelber PhD, of the Dana-Farber Cancer Institute.

Initially, in 2005, the HERA study showed Herceptin's superiority over just observation regarding its primary endpoint - does the medication offer significant benefit in disease free survival? Findings from the HERA and three other randomized trials involving over 13,000 women resulted in Herceptin's approval for those with early-stage HER2-positive breast cancer in the USA, Canada, European Union and several other parts of the world.

Roche says that over 1.2 million women have received Herceptin.

The latest study observed no new safety issues. Overall cardiac dysfunction rates remained the same in all patients.

Herceptin over 12 months, 24 months and 6 months studied

The HERA study compared 24 months Herceptin treatment to 12 months, while a separate PHARE study compared Herceptin treatment over 6 months to 12 months.

Xavier Pivot of the University de Franche Comte, France, said the results of the PHARE study were "inconclusive but tended in favor of 12 months of treatment instead of six months". After studying the data in more detail, Pivot said further results will be announced in December 2012.

Pivot added that a black and white answer regarding 6 or 12 months is unlikely.

Breast cancer

Roche informs that breast cancer is the most common cancer among female adults globally. Approximately 1.4 million new diagnoses of breast cancer are made annually. 450,000 women die from breast cancer each year.

In some types of breast cancer, human epidermal growth factor receptor 2 (HER2) are present on tumor cell surfaces. Patients with this protein in their tumors have what is known as HER2-positive breast cancer, and represent from 15% to 20% of all breast cancer patients. HER2 makes breast cancer cells much more aggressive.

What does Herceptin do in breast cancer?

Herceptin (trastuzumab) is a humanized monoclonal antibody that blocks HER2 function. Herceptin activates the body's immune system and undermines HER2 signaling.

Roche says Herceptin is effective in treating both early and metastatic HER-2 positive breast cancer. It can be given as monotherapy (on its own) or along with other standard chemotherapy. Trials have demonstrated that Herceptin improves overall survival.

In the USA, Herceptin is manufacture and sold by Genentech, by Chugai in Japan, and by Roche in the rest of the world.

How much does Herceptin cost?

A full one-year course of Herceptin treatment costs about $70,000. According to various media sources, Genentech has never explained why the drug is so expensive.

Australia has managed to knock the price down to $50,000. Several countries which have universal health care, including the UK, have had problems regarding price and including full Herceptin usage for breast cancer patients. In the UK, the National Health Service pays for cancer medication (patients get them free) if they have been approved for payment by NICE (National Institute for Clinical Excellence); if not the patient has to pay.

Cancer patients and advocacy groups from Ontario, Canada, eventually managed, after going to the highest levels in the courts, to get the Ontario Ministry of Health in July 2005 to agree to pay for Herceptin treatment.

An "affordable" version of trastuzumab is available in India after Roche struck a deal with Emcure of India.

Further reading:
"What Is Herceptin (trastuzumab)? What Is Herceptin For?"

Written by Christian Nordqvist