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Randomised trial testing observation (no radiotherapy) against radiotherapy in women with low-risk completely excised ER positive ductal carcinoma in situ (DCIS) of the breast on adjuvant endocrine therapy.

Disease site: Breast cancer

Treatment modality: Radiotherapy

Status: In active follow-up

Trial details

In the UK, DCIS currently comprises 20% of screen-detected cancers. It is generally agreed that adequate local treatment comprises either simple mastectomy alone or complete microscopic tumour excision and radiotherapy. Although radiotherapy has been shown to reduce the risk of recurrence, many clinicians are reluctant to use it in all patients due to the lack of evidence that it affects mortality. In the UK only 30% of patients with DCIS receive radiotherapy, whereas elsewhere in Europe and in the USA it is standard therapy.

Previous trials were not prospectively designed to identify low or high risk subgroups of DCIS patients. The purpose of this study is to identify, within a trial utilising adjuvant endocrine therapy, the group of patients who can be spared radiotherapy. The primary aims are to test the effects of withholding radiotherapy in terms of ipsilateral tumour relapse and quality of life. Secondary aims are to identify the minimum surgical margins required to minimise local recurrence rate and to identify molecular markers that predict for ipsilateral tumour recurrence. Substudies include a Quality of Life Study and Biological Marker Study.

Recruitment is due to open autumn 2004 with a target total of 2000 patients to be recruited.

Chief Investigator: Professor Nigel Bundred, University of Manchester

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: [email protected]

ISRCTN: 22614215

Sponsor: University of Manchester

Funding: Cancer Research UK (CRUK/05/005)

Publications and presentations

Mills J, A'Hern R, Bliss JM, Bundred N, Hopwood P, on behalf of the BASO-DCIS Trial Management Group. The psychological impact of the diagnosis and treatment of DCIS. Psychooncology. 2009;18(Suppl 2):S163-S64

Mills J, A'Hern R, Bliss JM, Bundred N, Hopwood P, on behalf of the BASO-DCIS Trial Management Group. The Psychological impact of the diagnosis and treatment of DCIS (BASO-DCISII CR UK 05/0005). National Cancer Research Institute (NCRI) Cancer Conference 2009; Nov 2009; Birmingham, UK. NCRI.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.