Thrombin Inhibition Preoperatively in Early Breast Cancer
|II||Non-CTIMP||Open||18 and over||University of South Manchester|| Eudract No: 2014-004909-33
• 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).
University of South Manchester / LCTU / NWSTC
The treatment group will be randomized 1:1 between:
Rivaroxaban will be administered orally for a minimum of 11 days and maximum of 17 days, but not within 24 hours of surgery102.
Following surgery, all patients will be followed up for 2 weeks
In patients receiving preoperative Rivaroxaban, to determine (in post treatment compared to pre-treatment patient samples) if:
To determine if there is a dose-response to Rivaroxaban in the above measures.
All the above markers will be compared in pre-treatment compared to post-treatment samples, and in post treatment Rivaroxaban compared to placebo arms. In addition, the Rivaroxaban subgroup (divided 1:1 to 20mg once daily [od] or 10mg Rivaroxaban od) will have within-group assessment of dose response using the above markers.
Changes in markers of proliferation (Ki67 and p27), apoptosis (cleaved Caspase 3, TUNEL), angiogenesis (CD31), cfDNA, cfDI, proteomics and changes in MFE and CTC numbers will be correlated to tumour and systemic thrombin pathway activation (tissue TF, TAT, PAR1 and plasma d-dimer, TF and TAT respectively).
To determine if Ki67 score on Tissue MicroArray (TMA) constructs correlation with whole section Ki67 score.
To determine if Ki67 score on TMA constructs determined manually correlates with automated Ki67 score
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