Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002580
Protocol/serial number
BR9401
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
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast
Intervention
Following surgery patients are randomised to one of four treatment arms:
1. Group A: Tamoxifen 20 mg daily for 5 years
2. Group B: Tamoxifen 20 mg daily for 5 years plus six cycles of CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy
3. Group C: Tamoxifen 20 mg daily for 5 years plus ovarian suppression
4. Group D: Tamoxifen 20 mg daily for 5 years, six cycles of CMF chemotherapy and ovarian suppression
Intervention type
Drug
Phase
Not Specified
Drug names
Tamoxifen
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/1993
Overall trial end date
31/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed invasive carcinoma of the breast
2. Pre-menopausal
3. No medical contraindications to treatment
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1000
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/1993
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Scottish Cancer 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
Basic results (scientific)
Publication list
1999 results in: https://europepmc.org/abstract/med/10663329 (added 14/02/2019)