Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SCTO37
Study information
Scientific title
Randomised trial of primary systemic therapy versus conventional therapy in operable 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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Breast
Intervention
1. Group A: Mastectomy, wide local excision and axillary clearance plus adjuvant tamoxifen or CMF chemotherapy (depending on menstrual and nodal status)
2. Group B: Primary systemic therapy either endocrine or CAP chemotherapy (depending on oestrogen receptor status) followed by mastectomy, wide local excision and axillary clearance, and adjuvant endocrine or chemotherapy depending on prior response of tumour
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
31/10/1995
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Operable carcinoma of the breast
2. Age <70 years
3. No medical contraindications to protocol treatments
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
31/10/1995
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 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