ICCG Neocent trial

Disease site: Breast Cancer

Treatment Modality: Combination Therapy

Status: Open to recruitment

Neocent is a multi-centre randomised, parallel group, comparative phase III neo-adjuvant study of chemotherapy versus endocrine therapy in postmenopausal patients with strongly ER positive primary breast cancer in whom it is felt cytoreductive pre-operative systemic therapy is indicated.

Neoadjuvant chemotherapy is a standard of care for down-staging of breast cancer pre-operatively. However, aromatase inhibitors (AIs) also have activity in this setting in postmenopausal women with oestrogen receptor (ER) positive breast cancer (Eiermann et al., 2001). In strongly ER positive breast cancer, chemotherapy efficacy is reduced, whereas, the efficacy of AIs appears greatest and it is unclear which treatment response is more efficacious.

Overall, 70% of breast cancers are ER positive, and in postmenopausal women 85% of these are strongly ER positive (Ellis M, 2003). This study will help clarify optimal treatment for this patient group.

The study is divided into two phases, a pilot phase and a main efficacy phase. The aim of the pilot study is to assess the feasibility of patient recruitment and tissue collection for a subsequent ‘main study’. The pilot study requires 20 patients per treatment group.

Neocent is coordinated by the ICCG in collaboration with the ICR-CTSU and is part of the NIHR portfolio.

This is an International Collaborative Cancer group (ICCG) trial