Randomised trial testing observation (no radiotherapy) against radiotherapy in women with low-risk completely excised oestrogen receptor positive ductal carcinoma in situ of the breast on adjuvant endocrine therapy

ISRCTN	ISRCTN22614215
DOI	https://doi.org/10.1186/ISRCTN22614215
ClinicalTrials.gov number	NCT00077168
Secondary identifying numbers	N0226152511

Submission date: 11/02/2004
Registration date: 13/04/2004
Last edited: 02/10/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nigel Bundred
Scientific

South Manchester University Hospital
Education and Research Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone	+ 44 (0)161 291 5859
Email	bundredn@manchester.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	NCRI/BASO UK DCIS II Trial
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	13/10/2004
Completion date	13/10/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	2000
Key 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.
Key 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
Date of first enrolment	13/10/2004
Date of final enrolment	13/10/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

South Manchester University Hospital

Manchester
M23 9LT
United Kingdom

Sponsor information

Sponsor not defined - Record supplied by Institute of Cancer Research (UK)
Not defined

c/o Institute of Cancer Research
123 Old Brompton Road
London
SW7 3RP
United Kingdom

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C1491/A4589)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No