Breast CancerFASTNCT00107497
Radiation Therapy in Treating Women With Localized Breast Cancer
A study testing Radiation therapy in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 19 sites in United Kingdom.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery. Read more about this study
- Who is it for?
- Ages 50 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 917 participants
- Where
- 19 sitesUnited Kingdom
- Study dates
- 5 Oct 2004to 9 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of invasive carcinoma of the breast
- Localized disease
- Pathological tumor size < 3.0 cm in diameter
- Axillary node negative
- At average or low risk of local tumor recurrence
- Must have undergone prior breast-preserving surgery
- No prior mastectomy
- Complete microscopic resection of tumor
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 50 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior neoadjuvant or adjuvant cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No concurrent lymphatic radiotherapy
- No concurrent radiotherapy boost to the breast
Surgery
- See Disease Characteristics
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United Kingdom19 sites
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Cumberland Infirmary
Carlisle, England, CA2 7HY
Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Halton Hospital - North Cheshire Hospitals NHS Trust
Cheshire, WA7 2DA
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Hereford Hospitals NHS Trust
Hereford, HR1 2ER
Ipswich Hospital NHS Trust
Ipswich, England, IP4 5PD
Christie Hospital NHS Trust
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, CH63 4JY
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ
University Hospital of North Staffordshire
Stoke-on-Trent, England, ST4 7LN
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT
Torbay Hospital
Torquay Devon, England, TQ2 7AA
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Worcester Royal Hospital
Worcester, England, WR5 1DD
Worthing Hospital
Worthing, England, BN11 2DH
About this study
Official title: Prospective Randomised Clinical Trial Testing 5.7 Gy and 6.0 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.
Read the detailed description
OBJECTIVES:
- Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic breast appearance, in women with localized breast cancer who are at average or low risk of recurrence.
- Compare tumor control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks.
- Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once a week for 5 weeks.
After completion of study treatment, patients are followed annually for 5-10 years.
PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this study within 12 months.
- Conditions
- Breast Cancer
- Being tested
- Radiation therapy
- Keywords
- stage I breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 50Gy in 25 fractions of radiation therapy over 5 weeks Receives: Radiation: Radiation therapy |
| Test group 1 | Active comparator | 30Gy in 5 fractions of radiation therapy over 5 weeks Receives: Radiation: Radiation therapy |
| Test group 2 | Active comparator | 28.5Gy in 5 fractions of radiation therapy over 5 weeks Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in photographic breast appearance
Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph
Measured: 2 years post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study start5 Oct 2004
- Primary completion9 Mar 2007
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 917 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John R. Yarnold, MD, FRCR, Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107497
- Sponsor's protocol ID
- CDR0000417730
- Other IDs
- ICR-04/MRE06/17
- Acronym
- FAST
- Status last verified
- Feb 2019
- First submitted
- 5 Apr 2005
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.
PubMed 32663119
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Clinical Trial Testing 5.7 Gy and 6.0 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST
- ClinicalTrials.gov ID
- NCT00107497
- Acronym / sponsor ID
- FAST / CDR0000417730
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 917 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- 5 Oct 2004 (actual)
- Primary completion
- 9 Mar 2007 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 6 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.
Detailed description
OBJECTIVES:
- Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic breast appearance, in women with localized breast cancer who are at average or low risk of recurrence.
- Compare tumor control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks.
- Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once a week for 5 weeks.
After completion of study treatment, patients are followed annually for 5-10 years.
PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this study within 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Radiation: Radiation therapy50Gy in 25 fractions of radiation therapy over 5 weeks |
| Test group 1 | Active comparator | Radiation: Radiation therapy30Gy in 5 fractions of radiation therapy over 5 weeks |
| Test group 2 | Active comparator | Radiation: Radiation therapy28.5Gy in 5 fractions of radiation therapy over 5 weeks |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapy | Radiation | Control, Test group 1, Test group 2 |
Primary outcome
Change in photographic breast appearance
Time frame: 2 years post randomisation
Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 32663119Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.
- First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015), Radiotherapy and Oncology, Volume 100, Issue 1, 2011, Pages 93 - 100Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R. Yarnold, MD, FRCR study chair
Royal Marsden NHS Foundation Trust
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation therapy in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 19 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in photographic breast appearance (time frame: 2 years post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00107497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.