Randomised trial testing dose escalated intensity modulated radiotherapy in women with higher than average local tumour recurrence risk after breast conservation therapy for early breast cancer

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Ng S, Kirby AM, Kilburn LS, Griffin C, Sydenham M, Lloyd L, Kirwan CC, Jefford M, Syndikus I, Bliss JM, Coles CE.

2025-11-27

10.1016/j.radonc.2025.111301

Five-year trends and baseline predictors of patient-reported adverse events following breast radiotherapy with a boost in the IMPORT HIGH phase III randomised controlled trial.

Ng S, Kilburn LS, Kirby AM, Griffin C, Sydenham M, Kirwan CC, Haviland JS, Bhattacharya IS, Jefford M, Syndikus I, Bliss JM, Coles CE, IMPORT Trialists.

2025-07-231 citations

10.1016/j.radonc.2025.111056

Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial.

Coles CE, Haviland JS, Kirby AM, Griffin CL, Sydenham MA, Titley JC, Bhattacharya I, Brunt AM, Chan HYC, Donovan EM, Eaton DJ, Emson M, Hopwood P, Jefford ML, Lightowlers SV, Sawyer EJ, Syndikus I, Tsang YM, Twyman NI, Yarnold JR, Bliss JM, IMPORT Trial Management Group.

2023-06-0874 citations

10.1016/s0140-6736(23)00619-0

Can routine data be used to support cancer clinical trials? A historical baseline on which to build: retrospective linkage of data from the TACT (CRUK 01/001) breast cancer trial and the National Cancer Data Repository.

Kilburn LS, Aresu M, Banerji J, Barrett-Lee P, Ellis P, Bliss JM.

2017-11-2311 citations

10.1186/s13063-017-2308-6

Interventions

The control arm will have standard dose radiotherapy to the whole breast Monday to Friday for 3 weeks (15 treatments). This will be followed by a sequential boost dose to the tumour bed Monday to Frid

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 26/02/2019: 1. Operable unilateral breast cancer (T1-3, pN0- pN3a, M0 at presentation) 2. Breast conserving surgery 3. Age greater than or equal to 18 years 4. Histological confirmation of invasive carcinoma 5. Complete microscopic resection 6. Patient requires a tumour bed boost plus whole breast radiotherapy for inclusion within the trial 7. Written informed consent and available for follow-up Previous inclusion criteria: 1. Age greater than or equal to 18 years 2. Operable, unilateral breast cancer (T1-3, N0-1, M0 at presentation) 3. Breast conserving surgery 4. Histological confirmation of invasive carcinoma 5. Complete microscopic resection 6. Patient requires a tumour bed boost plus whole breast radiotherapy 7. Written informed consent and availability for follow-up

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 26/02/2019: 1. Past history of malignancy except: 1.1. Basal cell skin cancer and CIN cervix uteri or 1.2. Non breast malignancy allowed if treated with curative intent and at least 5 years disease-free 2. Mastectomy 3. Concomitant chemotherapy (primary or sequential chemotherapy allowed). 4. Presence of ipsilateral breast implant Previous exclusion criteria: 1. Previous malignancy (other than non-melanomatous skin cancer and Carcinoma In Situ [CIS] of the cervix) 2. Mastectomy 3. Concomitant chemotherapy (sequential chemotherapy allowed) 4. Radiotherapy prescription includes posterior axillary boost field

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 26/02/2019: Local tumour control measured by reported ipsilateral events at 5 years Previous primary outcome measure: Palpable induration in the ipsilateral breast, measured at yearly follow-up visits by physician examination and also at baseline (before radiotherapy) and at years 3 and 5 by photographic assessment years. Outcome from these will be correlated at years 3 and 5.	—

Measure

Time frame

Current primary outcome measure as of 26/02/2019: Local tumour control measured by reported ipsilateral events at 5 years Previous primary outcome measure: Palpable induration in the ipsilateral breast, measured at yearly follow-up visits by physician examination and also at baseline (before radiotherapy) and at years 3 and 5 by photographic assessment years. Outcome from these will be correlated at years 3 and 5.

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Secondary

Measure	Time frame
Current secondary outcome measures as of 26/02/2019: 1. Induration in the ipsilateral breast by clinician assessed changes, patient reported changes, photographic assessments at baseline and 5 years 2. Other late adverse effects in normal tissues reported on CRFs by clinical assessment at 5 years 3. Quality of life reported by patients at baseline, 6 months, 1, 3 and 5 years 4. Location of tumour relapse in breast reported on CRFs and/or assessed by review of scans at 5 years 5. Contralateral primary tumours reported by CRFs at 5 years 6. Regional and distant metastases reported by CRFs at 5 years 7. Survival reported by CRFs at 5 years Previous secondary outcome measures: 1. Quality of life, measured at baseline, 6 months and years 1, 3 and 5 Other secondary outcomes will be measured at annual follow up visits for 10 years and also during the trial by completion of case report forms: 2. Other late adverse effects of radiotherapy in normal tissues 3. Local tumour control 4. Location of tumour relapse in breast 5. Contralateral primary tumours 6. Regional and distant metastases 7. Survival	—

Measure

Time frame

Current secondary outcome measures as of 26/02/2019: 1. Induration in the ipsilateral breast by clinician assessed changes, patient reported changes, photographic assessments at baseline and 5 years 2. Other late adverse effects in normal tissues reported on CRFs by clinical assessment at 5 years 3. Quality of life reported by patients at baseline, 6 months, 1, 3 and 5 years 4. Location of tumour relapse in breast reported on CRFs and/or assessed by review of scans at 5 years 5. Contralateral primary tumours reported by CRFs at 5 years 6. Regional and distant metastases reported by CRFs at 5 years 7. Survival reported by CRFs at 5 years Previous secondary outcome measures: 1. Quality of life, measured at baseline, 6 months and years 1, 3 and 5 Other secondary outcomes will be measured at annual follow up visits for 10 years and also during the trial by completion of case report forms: 2. Other late adverse effects of radiotherapy in normal tissues 3. Local tumour control 4. Location of tumour relapse in breast 5. Contralateral primary tumours 6. Regional and distant metastases 7. Survival

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Countries

England, United Kingdom

Outcome results

None listed