Condition category
Cancer
Date applied
01/02/2006
Date assigned
01/02/2006
Last edited
22/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Trevor Powles

ORCID ID

Contact details

Parkside Oncology Clinic
49 Parkside
Wimbledon
London
SW19 4NB
United Kingdom

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 measures

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

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

http://www.royalmarsden.org

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

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16542503

Publication citations

  1. 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.

Additional files

Editorial Notes