SOLD trial confirms 12 months of Herceptin* (trastuzumab) is standard of care

The SOLD¹ (The Synergism Or Long Duration) study was sponsored by the Finnish Breast Cancer Group and PHARMAC in New Zealand.

Results showed, at 5 years, patients with breast cancer were more likely to have their cancer return or die if their Herceptin was stopped at 9 weeks compared to a full 12 months.*

The authors concluded on stage at SABCS that “Chemotherapy plus 1-year of anti-HER2 therapy should remain the standard.”

The study looked at whether patients get the same benefit from using Herceptin for 9 weeks as they do for 12 months, when used with chemotherapy in early HER2-positive breast cancer. The results of the study were presented today at the San Antonio Breast Cancer Symposium (SABCS).

Herceptin^® (trastuzumab) is a treatment for the 20-25% of breast cancer patients whose tumours have too much HER2-protein, which makes their disease more aggressive.

The current global standard of care for early HER2-positive breast cancer is 12 months of Herceptin. This practice is supported by the results of four large trials in more than 10,000 women which showed that 12 months of Herceptin significantly reduced the recurrence of breast cancer, compared to women who received chemotherapy alone.

The SOLD study involving 2,100 women with early HER2-positive breast cancer did not meet its primary end point of showing non-inferiority. Women receiving 9 weeks of Herceptin were at an increased risk of disease recurrence than patients who received Herceptin for 12 months.

Other studies evaluating shorter durations of Herceptin, such as PHARE (6 vs. 12 months) and Short-HER (9 weeks vs. 12 months) have also failed to show non-inferiority to 12 months of Herceptin.

In NZ, Herceptin is registered by Medsafe as a 12-month treatment for patients with early HER2-positive breast cancer and this has been available and funded by the government since 2008.

Roche NZ continues to support the research and development of innovative breast cancer treatments to improve outcomes for women.

Breast cancer is the most common cancer in women and leads to more than 600 deaths every year in NZ.

* (n=140 for 9 weeks vs. n=105 for 1 year).