TIP Trial

Overview

Systemic and tumour markers of coagulation are associated with more aggressive cancer behaviour. In vitro studies demonstrate that coagulation promotes tumour growth, invasion and metastases, and anticoagulants can inhibit this.

Rivaroxaban is a novel oral anticoagulant used in routine practice for stroke prevention in AF and thromboprophylaxis following hip and knee replacement surgery.

This study is re-purposing Rivaroxaban, to investigate its anti-cancer properties.

Objectives

This study aims to determine whether preoperative oral Factor Xa inhibitor (Rivaroxaban) in oestrogen receptor negative early breast cancer patients results in inhibition of tumour proliferation markers as determined by a reduction in tumour Ki67 from baseline (pretreatment) to post treatment (at time of surgical excision or research biopsy prior to commencing chemotherapy).

Inclusion criteria

• Provision of written informed consent.
• Female patients, age over 18, with histological confirmation of ER negative invasive breast carcinoma
• AJCC Stage 1- 3 with primary tumour in the breast amenable to biopsies
• Scheduled to have definitive breast surgery or neoadjuvant chemotherapy 11 or more days after commencement of treatment
• Tumour size ≥10mm (large enough to provide sufficient tissue to be taken by core-cut or tru-cut biopsy (free-hand or under ultrasound guidance as per local protocols).