TAILOR X

• Research type

  Research Study

• Full title

  Program for the assessment of clinical cancer tests (PACCT-1) Trial Assigning Individualised Options for Treatment

• Sponsor organisation

  The All-Ireland Cooperative Oncology Research Group (ICORG)

• Eudract number

  2007-003810-32

• Research summary

  Mortality from breast cancer has declined over the last 10 years, because of improvements in screening, hormonal treatments and chemotherapy. Adjuvant chemotherapy is recommended if the risk of recurrence is at least 10% despite hormonal therapy. Research is focusing on identifying who should not receive adjuvant chemotherapy. This study uses a new test (OncotypeDx) to analyse tumours and determine the risk of recurrence. Patients with node negative, hormone receptor positive early breast cancer will be invited to participate. Approximately 80-85% of patients with this stage of disease are expected to be alive with no signs of breast cancer recurrence at 10 years with hormonal therapy alone and this may be improved by an estimated 3-4% with adjuvant chemotherapy. However, this means that 100 women must be treated in order to benefit only 3 or 4 patients. Given that chemotherapy carries a risk of side effects, it is necessary to refine prognostic markers.Oncotype DX is a multi-gene assay that'ses the expression levels of 21 genes to assign a Recurrence Score. Patients are then subdivided into low (RS<18), intermediate (RS 18-30) and high risk (RS>31) of recurrence. The PACCT-1 trial is a prospective trial to determine if Oncotype DX can accurately identify individuals who do not require adjuvant chemotherapy.Patients with a Recurrence Score of <11 will enter treatment arm A, where patients will receive hormone therapy of the treating physicians choice.Patients with a Recurrence Score of >25 will enter treatment arm D, where patients will receive chemotherapy and hormone therapy of the treating physicians choice.Patients with a Recurrence Score of 11-25 will be randomised to receive treatment arm B, hormone therapy of the treating physicians choice OR treatment arm C, chemotherapy and hormone therapy of the treating physicians choice.

• REC name

  HSC REC B

• REC reference

  09/NIR03/28

• Date of REC Opinion

  5 Jun 2009

• REC opinion

  Further Information Favourable Opinion