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
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