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IMPORT LOW: A trial comparing different ways of giving radiotherapy for low risk early stage breast cancer

In follow-up

What is the study about?

IMPORT LOW investigates whether a more targeted type of radiotherapy for people with early breast cancer can reduce side effects without reducing how well the treatment works.

After people have surgery to remove breast cancer, radiotherapy treatment is normally given to the whole breast. This can cause long term side effects in the surrounding non-cancerous tissue due to radiation exposure.

Cancer is most likely to return in the area of the breast closest to the site of the original tumour. If the cancer has a low overall risk of returning, based on analysis of the tissue removed at surgery, it may be possible to give radiotherapy focused on the area where the cancer was, reducing the amount of radiotherapy given to the rest of the breast.

IMPORT LOW is investigating whether targeting the highest dose of radiotherapy at the site of the cancer will be as good at preventing cancer from returning as treating the whole breast. The trial will also investigate the impact of reducing the area receiving the high dose radiotherapy on long term side effects and breast appearance.

Who is included in the study?

People with low risk breast cancer who were recommended a course of radiotherapy after surgery were included in IMPORT LOW. 2,018 people joined the study from 71 NHS hospitals across the UK.

What are the study treatments?

IMPORT LOW included three treatment groups:

  • Standard treatment - fifteen daily doses of radiotherapy given to the whole breast over three weeks
  • Test group one – fifteen daily doses of radiotherapy over three weeks, with the standard dose given to the area where the cancer was  and a lower dose given to the rest of the breast.
  • Test group two - fifteen daily doses of radiotherapy over three weeks, with the standard dose given to the area where the cancer was  and no radiotherapy to the rest of the breast.

Participants have regular check ups during and after their treatment and we collect information about how they are getting on until the study is completed.

Study Results

Lay summary of primary analysis

Primary publication 

Further information for participants 

Patient information sheet (centres with substudies)

Patient information sheet (centres without substudies)

A detailed summary is available on Cancer Research UK's website.

Further information for healthcare professionals 

Protocol

Contact details and regulatory information

Chief Investigator: Professor Charlotte Coles, University of Cambridge and Cambridge University Hospitals NHS Foundation Trusts

ICR-CTSU Scientific Lead:  Professor Judith Bliss

Trial management contact: [email protected] 

Sponsor: The Institute of Cancer Research 

Funding: Cancer Research UK (CRUK/06/003) and the Department of Health

Trial identifiers

REC reference: 06/Q1605/128 

ISRCTN12852634

Publications and presentations

Charlotte E Coles, Clare L Griffin, Anna M Kirby, Jenny Titley, Rajiv K Agrawal, Abdulla Alhasso, Indrani S Bhattacharya, Adrian M Brunt, Laura Ciurlionis, Charlie Chan, Ellen M Donovan, Marie A Emson, Adrian N Harnett, Joanne S Haviland, Penelope Hopwood, Monica L Jefford, Ronald Kaggwa, Elinor J Sawyer, Isabel Syndikus, Yat M Tsang, Duncan A Wheatley, Maggie Wilcox, John R Yarnold, Judith M Bliss on behalf of the IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. The Lancet published on-line 2nd August 2017.

C Coles, R Agrawal, ML Ah-See, H Algurafi, A Alhasso, AM Brunt, C Chan, C Griffin, A Harnett, P Hopwood, A Kirby, E Sawyer, I Syndikus, J Titley, Y Tsang, D Wheatley, M Wilcox, J Yarnold, JM Bliss and on behalf of the IMPORT TMG. Partial breast radiotherapy for women with early breast cancer: first results of local recurrence data for IMPORT LOW (CRUK/06/003).  Late breaking abstract presentation at EBCC, 09/03/2016, Amsterdam.

Partial breast radiotherapy for women with early breast cancer: first analysis of late cosmesis adverse events from IMPORT LOW (CRUK06/003). On behalf of the IMPORT Trial Management Group. Abstract number EBCC 0454; Oral presentation, EBCC-9, Glasgow, Scotland. 19 – 21 March 2014

Ciurlionis L, Tsang Y, Titley J, Coles CE, Yarnold J, Bliss J, on behalf of the Import Trial Management Group. Interim analysis of treatment plans in the IMPORT LOW Trial. NCRI National Cancer Conference; 2010; Liverpool

Coles C, Titley J, Bliss JM, Chan C, Ciurlionis L, Haviland J, Sydenham M, Tsang Y, Wishart G, Yarnold J, on behalf of the START Trial Management Group. IMPORT LOW re-visited: How strategic trial management has increased average monthly accrual. NCRI National Cancer Conference; 2009; Birmingham

Mills J, Haviland J, Bliss J, Hopwood P, on behalf of the IMPORT Low & Start Trial Management Groups. The IMPORT LOW Quality of Life Study: What we have learnt from the START Trial. NCRI National Cancer Conference; 2008 ;Birmingham. 

Sydenham M, Bliss J, Coles C, Donovan E, Evans P, Haviland J, Yarnold J, on behalf of the Import Trial Management Group. IMPORT LOW: Changing service delivery to optimise trial recruitment. NCRI National Cancer Conference; 2008; Birmingham. 

Tsang Y, on behalf of the Import Trial Working Party. Moving UK breast radiotherapy forward in the IMPORT LOW Trial - enabling safe change of practice through quality assurance (QA). NCRI National Cancer Conference; 2008; Birmingham.

Clinical trials

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