{"registry": "ISRCTN", "registryId": "ISRCTN12852634", "source": "https://www.isrctn.com/ISRCTN12852634", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN12852634/format/default", "fetchedAt": "2026-10-07T17:01:02.937153Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Randomised trial testing Intensity Modulated radiotherapy and Partial Organ RadioTherapy following breast conservation surgery for early breast cancer", "scientificTitle": "Randomised trial testing Intensity Modulated radiotherapy and Partial Organ RadioTherapy following breast conservation surgery for early breast cancer", "acronym": "IMPORT LOW", "hypothesis": "To test partial breast radiotherapy delivered using intensity modulated techniques following complete local tumour excision of low risk early stage breast cancer.\n\nA related study IMPORT HIGH is registered with ISRCTN47437448.\n\nAdded 27/11/2025:\nAdditional Data Linkage Information:\nParticipants from this trial will also be included in the INTERACT project which will link to their data held by NHS England. For more information, please see the INTERACT website: https://www.icr.ac.uk/interact.", "primaryOutcome": "Local tumour control in the ipsilateral breast", "secondaryOutcome": "1. Location of tumour relapse\n2. Contralateral primary tumours\n3. Regional and distant metastases\n4. Late adverse effects in normal tissues\n5. Quality of life (QL)\n6. Economic evaluation", "intervention": "\n\tThis is a randomised controlled trial for patients at low risk of local recurrence (less than 1% annual risk local recurrence after radiotherapy). \n\nControl group: current standard radiotherapy to the whole breast\nTest arm one: reduced radiotherapy to the whole breast with standard radiotherapy to the partial breast\nTest arm two: standard radiotherapy to the partial breast only\n\tOther\n\t\n\t\n      ", "condition": "\n\tBreast cancer\n\tCancer\n\tBreast cancer\n      ", "studyDesign": "Prospective randomized controlled trial", "overallEndDate": "2020-10-01T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00814567", "lastUpdated": "2025-11-27T14:19:32.29426484Z", "eligibility": {"inclusion": "Current inclusion criteria as of 26/02/2019:\n1.  Age greater than or equal to 50 years\n2.  Primary breast conservation surgery +/- adjuvant systemic therapy\n3.  Pathological tumour size  3.0 cm pT1-2 (< 3.1 cm, maximum microscopic diameter of invasive component)\n4.  Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)\n5.  Unifocal disease\n6.  Grade I, II or III\n7.  Lymphovascular invasion present or absent\n8.  Axillary lymph nodes negative or 1 to 3 nodes positive (pN0 or pN+(1-3))\n9.  Minimum microscopic margin of non-cancerous tissue  2 mm (excluding deep margin if this is at deep fascia)\n10.  No blood-borne metastases\n\nPrevious inclusion criteria:\n1. Age greater than or equal to 50 years\n2. Primary breast conservation surgery +/- adjuvant systemic therapy\n3. Pathological tumour size less than or equal to 2.0 cm pT1a-c (maximum microscopic diameter of invasive component)\n4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)\n5. Unifocal disease (Grade I or II)\n6. Minimum microscopic margin of non-cancerous tissue greater than or equal to 2 mm (excluding deep margin if this is at deep fascia)\n7. No lympho-vascular invasion\n8. Axillary lymph nodes negative, PN0 (sentinel node biopsy & isolated tumour cells less than 0.2 mm allowed)\n9. No blood borne metastases", "exclusion": "Current exclusion criteria as of 26/02/2019:\n1. Previous malignancy (other than non-melanomatous skin cancer)\n2. Mastectomy\n3. Invasive carcinoma of classical lobular type\n4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is <3.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)\n5. Concurrent chemo-radiotherapy\n\nPrevious exclusion criteria:\n1. Previous malignancy (other than non-melanomatous skin cancer)\n2. Mastectomy\n3. Invasive carcinoma of classical lobular type\n4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is less than 2.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)\n5. Concurrent chemo-radiotherapy", "ageRange": "Mixed", "gender": "Female", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2007-03-01T00:00:00.000Z", "recruitmentEnd": "2010-10-05T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "1935", "totalFinalEnrolment": "2018"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "Institute of Cancer Research", "city": "Sutton", "state": "", "country": "England", "zip": "SM2 5PT"}], "sponsors": [{"organisation": "Institute of Cancer Research (UK)", "sponsorType": "Charity", "rorId": "https://ror.org/043jzw605"}], "funders": [{"name": "Cancer Research UK (UK)", "fundRef": "http://dx.doi.org/10.13039/501100000289"}, {"name": "Department of Health (UK)"}]}, "studySha256": "34906dc098d49f8d8db596f3b337fa6945f34d0656234d0ce7ac1eefc7ce6050"}