Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
23/02/2015
Prospective/Retrospective
Retrospectively 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

- - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BR3002

Study information

Scientific title

A collaborative trial to evaluate the role of radiotherapy and adjuvant tamoxifen in the conservative management of clinical stage I and II breast cancer

Acronym

Study hypothesis

Not provided at time of registration

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

Following surgery to remove the tumour patients are randomised into one of six treatment groups:
1. Group A: Tamoxifen daily for 2 years
2. Group B: Tamoxifen daily until recurrence
3. Group C: Short radiotherapy plus tamoxifen daily for 2 years
4. Group D: Short radiotherapy plus tamoxifen daily until recurrence
5. Group E: Long radiotherapy plus tamoxifen daily for 2 years
6. Group F: Long radiotherapy plus tamoxifen daily until recurrence

SYSTEMIC TREATMENT: Tamoxifen 20 mg daily to start immediately following surgery

POST-OPERATIVE RADIOTHERAPY:
Short Radiotherapy: 40 Gy in fifteen daily fractions given over 3 weeks with a supplementary boost to the local tumour site of 15 Gy in five daily fractions.
Long Radiotherapy: 50 Gy in twenty-five daily fractions given over 5 weeks with a supplementary boost to the local tumour site of 15 Gy in five daily fractions.

Intervention type

Drug

Phase

Not Applicable

Drug names

Tamoxifen

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1997

Overall trial end date

31/12/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven adenocarcinoma of breast
2. Tumour size <5 cm
3. No clinically palpable axillary nodes
4.. Have had an operation resulting in a cosmetically satisfactory breast
5. No evidence of systemic metastases
6. No previous treatment for a malignancy by radiotherapy or chemotherapy
7. Patients with Paget's disease of the nipple, bilateral breast cancer or lymphoedema of the breast are excluded
8. No previous or co-existing malignancies, except basal cell carcinoma of skin and in-situ carcinoma of cervix
9. Patients must be fit enough to receive any of the specified treatments

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1997

Recruitment end date

31/12/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

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

Publication citations

Additional files

Editorial Notes