Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/10/2012
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

Dr - -

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

BR9002

Study information

Scientific title

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

Other

Trial type

Not Specified

Patient information sheet

Condition

Breast cancer

Intervention

All patients receive wide local excision of primary tumour.

Following surgery patients are randomised to one of four treatment arms:
1. Arm A: Observation only.
2. Arm B: Tamoxifen, 20 mg daily for 5 years or until relapse.
3. Arm C: Radiotherapy only, the radiotherapy technique is at the discretion of the radiotherapist. Suggested fractionations are radiotherapy to the whole breast 40-50 Gy given in fifteen to twenty-five fractions followed by a boost to the tumour bed of 10-15 Gy in five to eight fractions. An iridium of caesium implant is an acceptable alternative.
4. Arm D: Radiotherapy as in Arm C plus tamoxifen, 20 mg daily for 5 years or until relapse.

Intervention type

Drug

Phase

Not Specified

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

25/03/1992

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged <70 years
2. Unilateral invasive breast carcinoma grade I or of a special type:
a. Tubular
b. Tubular/cribriform
c. Cribriform
d. Papillary
e. Mucoid
f. Not lobular, medullary or other rarer special types of breast carcinoma
3. Tumour size <2 cm
4. No evidence of vascular invasion
5. The histological examination of at least one lymph node is required. There should be no evidence of metastases
6. No distant metastases
7. No other systemic disease
8. No previous invasive malignant disease, except basal cell carcinoma of the skin adequately treated or adequately treated in situ carcinoma of the cervix

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Patients with bilateral breast cancer, Paget's disease of the nipple, in situ carcinoma only or tumours which are essentially ductal carcinoma in situ but with microinvasion are to be excluded.

Recruitment start date

25/03/1992

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Scottish Cancer Therapy Network (UK)

Sponsor details

Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Scottish Therapy Network (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2007 results in Blamey RW, Chetty U, Bates T. Radiotherapy and/or tamoxifen after conserving surgery for breast cancers of excellent prognosis: BASO II TRIAL. Eur J Cancer Suppl. 2007;5 O-11.

Publication citations

Additional files

Editorial Notes