Breast cancer

  • Quality standard
  • QS12
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Quality statement 4: ER and HER2 receptor status

Quality statement

People with newly diagnosed invasive breast cancer and those with recurrent breast cancer (if clinically appropriate) have their hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status of the tumour assessed. [2011, updated 2026]

Rationale

Information on the HR and HER2 status of breast cancer tumours is used to classify the primary tumour and decide how best to treat and manage the cancer. If breast cancer recurs, the HR and HER2 status of the tumour may be different from that of the original primary tumour. Therefore, recurrent tumours (either at the site of the primary tumour or metastatic tumours) should be assessed for their HR and HER2 status if a change in receptor status will lead to a change in management.

Quality measures

The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.

Structure

a) Evidence of local arrangements and written clinical protocols to ensure that people with newly diagnosed invasive breast cancer have the HR and HER2 status of the tumour assessed.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from local protocols and service specifications.

b) Evidence of local arrangements and written clinical protocols to ensure that people with recurrent breast cancer have the HR and HER2 status of the tumour assessed, if clinically appropriate.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from local protocols and service specifications.

Process

a) Proportion of people with newly diagnosed invasive breast cancer who have the HR status of the tumour assessed.

Numerator – the number of people in the denominator who have the HR status of the tumour assessed.

Denominator – the number of people with newly diagnosed invasive breast cancer.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records. The National Audit of Breast Cancer in Older Patients reported the percentage of patients aged 50 years and over with early invasive breast cancer who had oestrogen receptor status reported (by age group). The National Audit of Metastatic Breast Cancer reports the percentage of records with complete data for selected items for people diagnosed with metastatic breast cancer identified at the time of their initial breast cancer diagnosis in England and Wales, including oestrogen receptor status. The National Audit of Primary Breast Cancer reports the percentage of records with complete data for selected items for people diagnosed with primary breast cancer in England and Wales, including oestrogen receptor status.

b) Proportion of people with newly diagnosed invasive breast cancer who have the HER2 status of the tumour assessed.

Numerator – the number of people in the denominator who have the HER2 status of the tumour assessed.

Denominator – the number of people with newly diagnosed invasive breast cancer.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records. The National Audit of Breast Cancer in Older Patients reported the percentage of patients aged 50 years and over with early invasive breast cancer who had HER2 status reported (by age group). The National Audit of Metastatic Breast Cancer reports percentage of records with complete data for selected items for people diagnosed with metastatic breast cancer identified at the time of their initial breast cancer diagnosis in England and Wales, including HER2 status. The National Audit of Primary Breast Cancer reports the percentage of records with complete data for selected items for people diagnosed with primary breast cancer in England and Wales, including HER2 status.

c) Proportion of people with histologically confirmed recurrent breast cancer who have the HR status of the tumour assessed, if clinically appropriate.

Numerator – the number of people in the denominator who have the HR status of the tumour assessed, if clinically appropriate.

Denominator – the number of people with histologically confirmed recurrent breast cancer.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.

d) Proportion of people with histologically confirmed recurrent breast cancer who have the HER2 status of the tumour assessed, if clinically appropriate.

Numerator – the number of people in the denominator who have the HER2 status of the tumour assessed, if clinically appropriate.

Denominator – the number of people with histologically confirmed recurrent breast cancer.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.

Outcome

Breast cancer survival rates.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.

What the quality statement means for different audiences

Service providers (such as secondary care services and tertiary care specialist centres) ensure that systems are in place for the HR and HER2 status of the tumour to be assessed in people with newly diagnosed invasive breast cancer and those with recurrent breast cancer (if clinically appropriate).

Healthcare professionals (such as doctors, nurses and specialists) ensure the HR and HER2 status of the tumour are assessed in people with newly diagnosed invasive breast cancer and those with recurrent breast cancer (if clinically appropriate).

Commissioners ensure they commission services that assess the HR and HER2 status of the tumour for people with newly diagnosed invasive breast cancer and those with recurrent breast cancer (if clinically appropriate).

People with newly diagnosed invasive breast cancer or with breast cancer that has come back or spread have tissue from their tumour tested to find out more about the type of cancer (whether it is a type called hormone receptor-positive or human epidermal growth receptor 2-positive). This helps to make sure that the person has the treatment and care that will work best for them.

Source guidance

Definitions of terms used in this quality statement

Clinically appropriate

Where there is a recurrence of a breast tumour and it is suspected that the HR and HER-2 status may be different to the original tumour and will lead to a change in management. [Expert opinion]