Contact information
Type
Scientific
Primary contact
Prof Nigel Bundred
ORCID ID
Contact details
South Manchester University Hospital
Education and Research Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
+ 44 (0)161 291 5859
bundredn@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00077168
Protocol/serial number
N0226152511
Study information
Scientific title
Acronym
NCRI/BASO UK DCIS II Trial
Study hypothesis
To determine, in a randomised controlled trial, the effects of withholding radiotherapy (in terms of recurrence and quality of life) after complete removal of oestrogen receptor (ER) positive low-risk precancerous change in the breast (ductal carcinoma in situ [DCIS]) and in the presence of adjuvant endrocrine therapy.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ductal carcinoma in situ
Intervention
All patients will receive endocrine therapy: either as part of the IBIS II trial (which randomises between tamoxifen or anastrozole), otherwise all non-IBIS II patients will be prescribed tamoxifen 20 mg/day (for five years).
2000 eligible patients will be randomised in a ratio of 1:1 to either:
1. Radiotherapy plus tamoxifen or anastrozole
2. No radiotherapy plus tamoxifen or anastrozole
Intervention type
Drug
Phase
Not Specified
Drug names
Tamoxifen or anastrozole
Primary outcome measure
Proportion of patients developing a recurrence in the affected breast five years after primary surgery.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
13/10/2004
Overall trial end date
13/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Unifocal DCIS without an invasive component. Patients with microinvasion (defined as one or more foci of invasion each less than 1 mm) may be included
2. Complete microscopic excision with a MINIMUM radial margin of 1 mm
3. ER positive or progesterone receptor (PgR) positive (either more than 10% tumour cells staining for receptor or a cut point of more than two)
4. Maximum microscopic tumour diameter must be less than 30 mm (less than 15 mm if grade III)
5. Primary surgery within six months of randomisation
6. The majority of women will be postmenopausal and all should be between the ages of 50 and 75 years. Postmenopausal status is defined as meeting one or more of the following criteria:
6.1. Aged over 60
6.2. Bilateral oophorectomy
6.3. Aged under 60 with a uterus and amenorrhoea for at least 12 months
6.4. Aged under 60 without a uterus and with follicle-stimulating hormone (FSH) more than 20 IU/L
6.5. Off Hormone Replacement Therapy (HRT) for more than four weeks and with an FSH more than 20 IU/L. Premenopausal and perimenopausal women (over 50 years of age) are eligible for DCIS II but not for IBIS II study
7. Fully informed signed consent
8. Patient available for long-term follow up
All post-menopausal women will potentially be eligible for IBIS II.
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
2000
Participant exclusion criteria
1. Aged under 50 years
2. ER negative DCIS or PgR negative (less than 10% cell staining positive immunohistochemically or a cutpoint of less than two)
3. Any previous cancer in the past five years (except non-melanoma skin cancer or in situ cancer of the cervix)
4. Current treatment with anti-coagulants
5. Previous deep vein thrombosis or pulmonary embolus
6. Previous tamoxifen or raloxifene use for more than three months
7. Any woman with unexplained postmenopausal bleeding
8. Tumour incompletely excised
9. DCIS lesions equals 30 mm maximum microscopic diameter (more than 15 mm if grade III)
10. Patient treated by mastectomy
11. Patients unable to undergo follow-up
12. Any condition precluding full dose radiotherapy to the breast
Recruitment start date
13/10/2004
Recruitment end date
13/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South Manchester University Hospital
Manchester
M23 9LT
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C1491/A4589)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21145284
Publication citations
-
Results
Cuzick J, Sestak I, Pinder SE, Ellis IO, Forsyth S, Bundred NJ, Forbes JF, Bishop H, Fentiman IS, George WD, Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial., Lancet Oncol., 2011, 12, 1, 21-29, doi: 10.1016/S1470-2045(10)70266-7.