This guideline updates and replaces the NICE guideline on early and locally advanced breast cancer (CG80). This is because new evidence was identified in surveillance that could affect recommendations, and has already changed clinical practice in some locations.

People with symptoms that could be caused by breast cancer are referred by their GP to designated breast clinics in local hospitals (see NICE's guideline on suspected cancer: recognition and referral). In addition, eligible women are invited for screening through the NHS Breast Screening Programme (NHSBSP) in England or the Breast Test Wales Screening Programme (BTWSP) in Wales. For most people, whether they are referred following breast screening or after presentation to a GP, diagnosis in the breast clinic is made by triple assessment (clinical assessment, mammography and/or ultrasound imaging, and core biopsy and/or fine-needle aspiration cytology). It is best practice to carry out these assessments at the same visit (see NICE's cancer service guideline on improving outcomes in breast cancer).

Breast cancer is the most common cancer in the UK, with approximately 54,000 new cases of invasive disease and around 7,000 new cases of pre-invasive (in situ) disease diagnosed annually. Most of the breast cancers occur in women, but just over 300 men in the UK are also diagnosed with invasive breast cancer every year.

Most breast cancers are diagnosed at an early stage and are therefore potentially curable with modern treatments. Survival rates have improved over recent decades with almost 90% of women diagnosed with breast cancer surviving their disease for 5 or more years after diagnosis. Survival is, however, linked to the stage of the disease at diagnosis; only 15% of women diagnosed with stage IV disease are alive at 5 years. Breast cancer remains the leading cause of death in women aged 35 to 49 years and is second only to lung cancer as the leading cause of cancer death in all women.

The main risk factor for breast cancer is being female; the disease is 100 times less common in men. It is also a disease of ageing, with the risk of breast cancer increasing with increasing age. Some breast cancers are linked to lifestyle factors that include obesity, alcohol intake and use of hormone replacement therapy, whereas other lifestyle factors, including physical activity and breastfeeding, protect against breast cancer. About 5% of breast cancers are because of inherited mutations in high-risk genes such as BRCA1/2 and p53.

Groups that are covered

Adults (18 and over) with:

  • newly diagnosed invasive adenocarcinoma of the breast of any size (T1 to T4), with or without spread to locoregional lymph nodes (N0 to N3) and with no distant metastases (M0)

  • newly diagnosed ductal carcinoma in situ (DCIS)

  • Paget's disease of the breast.

Groups that are not covered

Adults (18 and over) with:

  • invasive adenocarcinoma of the breast and distant metastases (clinical or pathological M1)

  • rare breast tumours (for example, angiosarcoma or lymphoma)

  • benign breast tumours (for example, fibroadenoma)

  • phyllodes tumour

  • locally recurrent breast cancer or DCIS

  • lobular carcinoma in situ (LCIS)

  • no personal history of breast cancer and an increased risk of breast cancer due to family history.