{"registry": "ISRCTN", "registryId": "ISRCTN19906132", "source": "https://www.isrctn.com/ISRCTN19906132", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN19906132/format/default", "fetchedAt": "2026-10-07T17:00:57.803009Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A clinical trial testing a 1-week schedule of whole breast radiotherapy against a 3-week schedule", "scientificTitle": "Randomised clinical trial testing a 1-week course of curative whole breast radiotherapy against a standard 3-week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer", "acronym": "FAST-Forward", "hypothesis": "To identify a 5-fraction schedule of curative radiotherapy delivered in one week that is at least as effective and safe as the UK standard 15-fraction regimen after primary surgery for early breast cancer.", "primaryOutcome": "Ipsilateral local tumour control: Will be reported at the annual follow up visits. The tests will be performed when the need arises i.e. when the patient feels unwell or reports another lump etc. The tests will be carried out as routine clinical examinations i.e. X rays, computerised tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound.", "secondaryOutcome": "1. Early and late adverse effects in normal tissues\n2. Quality of life at baseline, 6, months and 2, 5 and 10 years post randomisation\n3. Contralateral primary tumours, regional and distant metastases\n4. Survival", "intervention": "\n\tPatients will be randomised equally between a standard 3-week schedule and two 1 week test schedules of whole breast radiotherapy\n\nWhole breast radiotherapy schedules:\nStandard group - 40 Gy in 15 fractions over 15 days (not weekends)\nTest group 1 - 27 Gy in 5 fractions over 5 days (not weekends)\nTest group 2 - 26 Gy in 5 fractions over 5 days (not weekends)\n\nPatients will be followed up for a minimum of 10 years.\n\nThere are Quality of Life and a photographic sub-studies, each with 2196 patients. Quality of Life questionnaires will be completed at baseline, 6, months and 2, 5 and 10 years post randomisation. Photographs will be taken at baseline and 2, 5 and 10 years post randomisation.\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.\n\tOther\n\t\n\t\n      ", "condition": "\n\tBreast cancer\n\tCancer\n\tMalignant neoplasm of breast\n      ", "studyDesign": "Phase III randomized controlled multi-centre trial", "overallEndDate": "2028-10-02T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2026-05-18T12:59:14.279325039Z", "eligibility": {"inclusion": "1. Age more than or equal to 18 years\n2. Female or male\n3. Invasive carcinoma of the breast\n4. Breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed)\n5. Axillary staging and/or dissection\n6. Complete microscopic excision of primary tumour\n7. Stage pT1-3 pN0-1 M0 disease\n8. Written informed consent\n9. Able to comply with follow up\n\nConcurrent trastuzumab and hormone therapy is allowed", "exclusion": "1. Past history of malignancy except basal cell skin cancer and cervical intraepithelial neoplasia (CIN) or non-breast malignancy allowed if treated with curative intent and at least 5 years disease free\n2. Contralateral breast cancer, including ductal carcinoma in-situ (DCIS), irrespective of date of diagnosis\n3. Breast reconstruction using implants\n4. Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)\n5. Radiotherapy to any regional lymph node areas (excepting lower axilla included in standard tangential fields to breast/chest wall)", "ageRange": "Mixed", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2011-09-01T00:00:00.000Z", "recruitmentEnd": "2018-10-02T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "4600", "totalFinalEnrolment": "4579"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "Academic Radiotherapy", "city": "Sutton", "state": "", "country": "England", "zip": "SM2 5PT"}], "sponsors": [{"organisation": "Institute of Cancer Research", "sponsorType": "Research organisation", "rorId": "https://ror.org/00dpztj76"}], "funders": [{"name": "Health Technology Assessment Programme", "fundRef": "http://dx.doi.org/10.13039/501100000664"}]}, "studySha256": "6c758c726c826888e4a0e47ff2fb6e2043541dd2960c8f7440c45871d0108c67"}