Condition category
Cancer
Date applied
11/02/2004
Date assigned
13/04/2004
Last edited
02/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Not defined

Website

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

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21145284

Publication citations

  1. 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.

Additional files

Editorial Notes