Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
That the use of the anti-osteolytic bisphosphonate clodronate will prevent the development of bone metastases in patients with primary operable breast cancer
Ethics approval
Royal Marsden Hospital Research Ethics Committee, protocol number 444, approval received 1988
Study design
Randomised, double-blind, placebo-controlled, multicentre, phase III trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
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
Clodronate 1600 mg taken orally per day for two years
Intervention type
Drug
Phase
Phase III
Drug names
Bisphosphonate clodronate
Primary outcome measure
Time to first bone metastases over five-year study period
Secondary outcome measures
Survival
Overall trial start date
01/01/1989
Overall trial end date
01/01/1995
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Histologically or cytologically confirmed primary operable breast cancer with no evidence of metastases
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1000
Participant exclusion criteria
1. Significant renal, hepatic or non-malignant bone disease
2. Previous history of malignant disease
3. Prior bisphosphonate use
Recruitment start date
01/01/1989
Recruitment end date
01/01/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Parkside Oncology Clinic
London
SW19 4NB
United Kingdom
Sponsor information
Organisation
Royal Marsden Hospital (UK), secondary sponsor Schering (Germany)
Sponsor details
Downs Road
Sutton
SM2 5PT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Royal Marsden hospital research fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Leiras Oy (Finland)
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
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16542503
Publication citations
-
Results
Powles T, Paterson A, McCloskey E, Schein P, Scheffler B, Tidy A, Ashley S, Smith I, Ottestad L, Kanis J, Reduction in bone relapse and improved survival with oral clodronate for adjuvant treatment of operable breast cancer [ISRCTN83688026]., Breast Cancer Res., 2006, 8, 2, R13, doi: 10.1186/bcr1384.