School of Medical Sciences SOLD

A randomised phase III study comparing trastuzumab plus docetaxel (HT) followed by 5-FU, epirubicin, and cyclophosphamide (FEC) to the same regimen followed by single-agent trastuzumab as adjuvant treatments for early breast cancer The Synergism Or Long Duration (SOLD) study

Registration number:	EudraCT number:2007-002016-26
Ethics number:	MEC/08/03/033

This trial involves early breast cancer patients who are HER2 positive.

Approximately 20% of all breast cancers express HER2. HER2-positive breast cancers are generally associated with a less favourable outcome.

Trastuzumab is a biological cancer treatment that targets HER2. Results from large prospective, randomised trials with limited follow-up have indicated that giving adjuvant trastuzumab for 12 months reduces the risk of breast cancer recurrence but this has also been associated with some cardiac problems.

In a smaller trial, women received nine weekly infusions of trastuzumab with their chemotherapy. The risk of the cancer returning and the risk of dying were significantly reduced in the women who had trastuzumab.

The best duration of trastuzumab for early breast cancer is currently uncertain. This trial will look at whether nine weeks of trastuzumab can be given safely with chemotherapy and if it works as well as receiving 12 months of trastuzumab.

All trial patients will receive taxane and anthracycline containing chemotherapy. In addition, half of the patients will receive nine weeks of trastuzumab and half will receive 12 months of trastuzumab. Patients will be followed up three weekly during the first year and then annually for a minimum of five years. Patients will undergo regular clinical assessments and cardiac monitoring.