the prognosis of distant recurrence and metastases in ER+ve, HER2-ve primary breast cancer patients at intermediate risk who have undergone surgical tumour removal? Is EndoPredict® (EPclin Score) when used in conjunction with current clinical practice, as safe, effective and cost-effective as MammaPrint or Oncotype DX when used in conjunction with current clinical practice, for determining the prognosis of distant recurrence and metastases in ER+ve, primary breast cancer patients at intermediate risk who have undergone surgical tumour removal? Table 7 PICO criteria for evaluating predictive value for recurrence in patients at intermediate risk who have been classified as high risk or low risk by EndoPredict® Prior tests Patients Intervention Comparators Outcomes to be assessed IHC and ISH for Patients with primary breast Endocrine therapy Endocrine therapy Predictive value for ER and HER2 cancer, suitable for adjuvant plus chemotherapy alone distant recurrence or status, chemotherapy, and who have metastases i.e. the histopathology ER+ve, HER2-ve status, interaction between for tumour size tumour size and nodal status low and high risk and nodal determined following tumour status and treatment status following removal, at intermediate risk surgery of distant recurrence or metastases* Subgroups as determined by EndoPredict: Low risk High risk IHC = immunohistochemistry; ISH = in situ hybridisation; ER+ve = oestrogen receptor positive; HER2-ve = human epidermal growth receptor negative *Intermediate risk is defined as tumour size ≥ 2cm, ; or Grade 2; or one to three lymph nodes involved in metastatic disease (nodes include micrometastases but not isolated tumour cells). Maximum tumour size for intermediate risk group to be determined by subgroup analysis. Direct research question for predictive value Is EndoPredict able to predict which patients will benefit from chemotherapy plus endocrine therapy compared with endocrine therapy alone in patients who are intermediate risk of recurrence or metastases? Note: Evidence from a randomised controlled trial is required for this question due to the high risk of selection bias in observational studies.
the prognosis of distant recurrence and metastases in ER+ve, HER2-ve primary breast cancer patients at intermediate risk who have undergone surgical tumour removal? Is EndoPredict® (EPclin Score) when used in conjunction with current clinical practice, as safe, effective and cost-effective as MammaPrint or Oncotype DX when used in conjunction with current clinical practice, for determining the prognosis of distant recurrence and metastases in ER+ve, primary breast cancer patients at intermediate risk who have undergone surgical tumour removal? Table 7 PICO criteria for evaluating predictive value for recurrence in patients at intermediate risk who have been classified as high risk or low risk by EndoPredict® Prior tests Patients Intervention Comparators Outcomes to be assessed IHC and ISH for ER and HER2 status, histopathology for tumour size and nodal status following surgery Patients with primary breast cancer, suitable for adjuvant chemotherapy, and who have ER+ve, HER2-ve status, tumour size and nodal status determined following tumour removal, at intermediate risk of distant recurrence or metastases* Subgroups as determined by EndoPredict: Low risk High risk Endocrine therapy plus chemotherapy Endocrine therapy alone Predictive value for distant recurrence or metastases i.e. the interaction between low and high risk status and treatment IHC = immunohistochemistry; ISH = in situ hybridisation; ER+ve = oestrogen receptor positive; HER2-ve = human epidermal growth receptor negative *Intermediate risk is defined as tumour size ≥ 2cm, ; or Grade 2; or one to three lymph nodes involved in metastatic disease (nodes include micrometastases but not isolated tumour cells). Maximum tumour size for intermediate risk group to be determined by subgroup analysis. Direct research question for predictive value Is EndoPredict able to predict which patients will benefit from chemotherapy plus endocrine therapy compared with endocrine therapy alone in patients who are intermediate risk of recurrence or metastases? Note: Evidence from a randomised controlled trial is required for this question due to the high risk of selection bias in observational studies.