Neocent

A Neoadjuvant Study of Chemotherapy versus Endocrine Therapy in Postmenopausal Patients with Primary Breast Cancer

Aim

Neocent aims to compare the effectiveness and tolerability of chemotherapy (FEC₁₀₀) versus hormonal treatment (Letrozole) in postmenopausal patients with strongly oestrogen receptor positive primary breast cancer. Chemotherapy and hormone therapy are both standard treatment options commonly used to treat patients with breast cancer in order to reduce the size of the tumour (down-stage) before they have surgery.

Background

Neoadjuvant chemotherapy is a standard of care for down-staging of breast cancer pre-operatively. However, hormone therapy using aromatase inhibitors (AIs) also has a role in treating 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.

Design

Neocent is a multi-centre, randomised, parallel group, phase III study. Patients are randomised to either chemotherapy or hormonal therapy for a period of 18 to 23 weeks, prior to surgery.

Feasibility Study

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. The pilot study requires 20 patients per treatment group. The feasibility study is to be followed with a larger study comparing the treatments on 358 patients per treatment group. The results from this feasibility study and the larger study will be combined. 

Neocent is open to hospitals across the UK and new centres are welcome.

Substudies

A sub-study will be investigating ways of predicting who will respond to treatment, by looking at substances in blood and tissue samples. An optional sub-study is being undertaken to measure the quality of life of patients during and following the treatments.  As well as looking at tumour response using ultrasound / mammography, an optional sub-study is also examining response using Magnetic Resonance Imaging (MRI).