Breast cancer Cancer
Conditions
Interventions
Patients will be treated using standard radiotherapy to the breast +/- nodes with a SIB to the tumour bed and randomised on a 1:1:1 basis to one of the following schedules:
• Standard radiotherapy to
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. Histologically confirmed breast cancer (T1-T3, N0-3, M0) (multifocal disease is allowed) requiring a tumour bed boost plus whole breast radiotherapy +/- radiotherapy to nodes* (axilla +/- internal mammary chain) or DCIS (Tis, N0-3, M0) requiring a tumour bed boost according to local centre policy 3. Treated with breast conservation surgery 4. Complete microscopic resection (invasive cancer and/or DCIS clear of ink on radial margins or, if at margin, surgeon confirms no further breast tissue to excise) 5. Patient can provide informed consent * Axilla levels as per MDM recommendation NB Patients with synchronous bilateral breast cancer can be included as long as the disease on at least one side fulfils the inclusion criteria above. Where the patient has synchronous bilateral disease and needs a tumour bed boost on both sides, both sides will need to fulfil the inclusion criteria for the patient to be eligible for the trial
Exclusion criteria
Exclusion criteria: 1. Treated with ipsilateral mastectomy 2. Previous radiotherapy to ipsilateral chest area that precludes delivery of a radical dose of adjuvant radiotherapy to the breast with tumour bed boost. NB for any scenarios where there is overlap with previous radiotherapy approval must be sought from the FAST-Forward Boost trial team prior to randomisation 3. Presence of metastatic disease 4. Unavailable for any trial related follow-up 5. History of malignancy except non-melanomatous skin cancer, CIS cervix, previously unirradiated precancerous changes in the breast (including ductal carcinoma in-situ and lobular carcinoma in-situ), and non-breast malignancy if curative intent and at least 5 years disease free 6. Pregnant and/or currently breast feeding 7. Participating in the PARABLE trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ipsilateral breast tumour recurrence (IBTR) measured using patient records at 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported acute radiotherapy adverse effects, with a focus on skin, breast, and oesophageal effects, are measured using PRO-CTCAE and trial-specific questionnaires at baseline, weekly for 7 weeks from the start of radiotherapy, and at 3 months 2. Patient-reported late effects on quality of life, with a focus on breast symptoms and shoulder/arm functioning, are measured using EORTC QLQ BR-23 and trial-specific questionnaires at baseline, weeks 1, 3, and 5 from the start of radiotherapy, and at 3 months, 1, 2, 3, 4, and 5 years 3. Patient-reported fatigue is measured using EORTC QLQ FA-12 at baseline, weeks 1, 3, and 5 from the start of radiotherapy, and at 3 months, 1, 2, 3, 4, and 5 years 4. Health-related quality of life is measured using EORTC QLQ C-30 and EQ5D-5L at baseline, weeks 1, 3, and 5 from the start of radiotherapy, and at 3 months, 1, 2, 3, 4, and 5 years 5. Body image is measured using the Body Image Scale (BIS) at baseline, weeks 1, 3, and 5 from the start of radiotherapy, and at 3 months, 1, 2, 3, 4, and 5 years 6. Clinician-reported acute radiotherapy adverse effects, with a focus on skin, oesophageal, and lung toxicity, are measured using CTCAE v5.0 and RTOG at baseline, weekly for 7 weeks from the start of radiotherapy, and at 3 months 7. Clinician-reported breast oedema is measured using trial-specific tools at baseline, weekly for 7 weeks from the start of radiotherapy, and at 3 months 8. Clinician-reported late radiotherapy adverse effects, with a focus on normal tissue effects and cosmesis, are measured using tools developed in previous breast radiotherapy trials and the Harvard-Harris scale at baseline, 3 months, 1, 3, and 5 years 9. Clinician-reported lung toxicity is measured using RTOG at baseline, 3 months, 1, 3, and 5 years 10. Recurrence-free survival, breast cancer-related survival, and overall survival are measured using NHS routinely collected data at baseline, 3 months, 1, 3, and 5 years 11. Cost-effectiveness is measured | — |
Countries
England, Ireland, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactMark Sydenham
Outcome results
None listed