Plain English Summary
Study website
Contact information
Type
Scientific
Contact name
Prof Murray Brunt
ORCID ID
Contact details
School of Medicine
Keele University
Newcastle
ST5 5BG
United Kingdom
+44 (0)208 722 4104
m.brunt@keele.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
58575
ClinicalTrials.gov number
Nil known
Protocol/serial number
HTA 09/01/47, ICR-CTSU/2010210026, IRAS 58575, NIHR150755
Study information
Scientific title
Randomised clinical trial testing a one week course of curative whole breast radiotherapy against a standard three week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer
Acronym
FAST-Forward
Study 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.
Ethics approval(s)
Approved 02/09/2011, NRES Committee South East Coast - Kent (now London - Brighton and
Sussex REC, Ground Floor, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)207 104 8241; brightonandsussex.rec@hra.nhs.uk), REC ref: 11-LO-0958
Study design
Phase III randomized controlled multi centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
https://www.icr.ac.uk/our-research/centres-and-collaborations/centres-at-the-icr/clinical-trials- and-statistics-unit/clinical-trials/fast_forward_page
Condition
Breast cancer
Intervention
Patients will be randomised equally between a standard 3-week schedule and two 1 week test schedules of whole breast radiotherapy
Whole breast radiotherapy schedules:
Standard group - 40 Gy in 15 fractions over 15 days (not weekends)
Test group 1 - 27 Gy in 5 fractions over 5 days (not weekends)
Test group 2 - 26 Gy in 5 fractions over 5 days (not weekends)
Patients will be followed up for a minimum of 10 years.
There 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.
Intervention type
Other
Primary outcome measure
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.
Secondary outcome measures
1. Early and late adverse effects in normal tissues
2. Quality of life at baseline, 6, months and 2, 5 and 10 years post randomisation
3. Contralateral primary tumours, regional and distant metastases
4. Survival
Overall study start date
01/09/2011
Overall study end date
02/10/2028
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age more than or equal to 18 years
2. Female or male
3. Invasive carcinoma of the breast
4. Breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed)
5. Axillary staging and/or dissection
6. Complete microscopic excision of primary tumour
7. Stage pT1-3 pN0-1 M0 disease
8. Written informed consent
9. Able to comply with follow up
Concurrent trastuzumab and hormone therapy is allowed
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
4600
Total final enrolment
4579
Participant exclusion criteria
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
2. Contralateral breast cancer, including ductal carcinoma in-situ (DCIS), irrespective of date of diagnosis
3. Breast reconstruction using implants
4. Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
5. Radiotherapy to any regional lymph node areas (excepting lower axilla included in standard tangential fields to breast/chest wall)
Recruitment start date
01/09/2011
Recruitment end date
02/10/2018
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Academic Radiotherapy
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Institute of Cancer Research
Sponsor details
123 Old Brompton Road
London
SW7 3PR
United Kingdom
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/05/2020 | 26/06/2020 | Yes | No |
| Plain English results | 03/05/2022 | No | Yes | ||
| Results article | 01/11/2023 | 23/11/2023 | Yes | No |