TOPIC II

Disease site: Breast Cancer

Treatment Modality: Chemotherapy

Status: In active follow-up

Multi-centre randomised trial of primary innovative chemotherapy as pre-operative treatment in patients with greater than 3cm diameter early breast cancer. The Phase II trial commenced in October 1998 to determine the feasibility and toxicity of the novel agent navelbine in combination with either epirubicin or mitoxantrone as compared with standard treatment adriamycin and cyclophosphamide. The pilot study completed recruitment in April 2000. The Phase III trial aims to compare treatments of navelbine and epirubicin with adriamycin and cyclophosphamide given 3 weekly for 6 courses in terms of disease free and overall survival; clinical and pathological objective tumour response; toxicity and side effects and increase the proportion of patients able to have breast conserving surgery. The trial closed to recruitment in December 2002 with 490 patients recruited from 27 centres throughout the UK.

Chief Investigator: Professor I. Smith, Royal Marsden Hospital. [Project No.0929]

ISRCTN: 72868621.

Publication

Smith, A’Hern, Coombes et al, 2003 ASCO Annual Meeting, Abstract No. 83. A Randomised neoadjuvant Chemotherapy Trial of Vinorelbine/Epirubicin (VE) vs standard Adriamycin/Cyclophosphamide (AC) in patients with greater than 3cm diameter operable breast cancer (TOPIC II)