BASO II: a randomised trial for the management of small well-differentiated and special type carcinomas of the breast

ISRCTN	ISRCTN47734678
DOI	https://doi.org/10.1186/ISRCTN47734678
ClinicalTrials.gov (NCT)	NCT00006030
Protocol serial number	BR9002
Sponsor	Scottish Cancer Therapy Network (UK)
Funder	Scottish Therapy Network (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	BASO II: a randomised trial for the management of small well-differentiated and special type carcinomas of the breast
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 Applicable
Drug / device / biological / vaccine name(s)	tamoxifen
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key 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
Key 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.
Date of first enrolment	25/03/1992
Date of final enrolment	31/12/2006

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013		Yes	No

14/02/2020: ClinicalTrials.gov number added.