Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/04/2015
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

- - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C120

Study information

Scientific title

A phase II, double blind, randomised, dose ranging, safety and efficacy trial of rapid intravenous infusion of Zoledronate versus Aredia in breast cancer patients with osteolytic metastases

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

Condition

Breast cancer

Intervention

All patients receive treatment for 9 months.

Patients are randomised to one of four treatment groups:
1. Group A: Zoledronate 0.4 mg in 50 ml normal saline rapid infusion every 4 weeks followed by 250 ml 0.9% normal saline 2 h infusion every 4 weeks.
2. Group B: Zoledronate 2 mg in 50 ml normal saline rapid infusion every 4 weeks followed by 250 ml 0.9% normal saline 2 h infusion every 4 weeks.
3. Group C: Zoledronate 4 mg in 50 ml normal saline rapid infusion every 4 weeks followed by 250 ml 0.9% normal saline 2 h infusion every 4 weeks.
4. Group D: Normal saline, 50 ml rapid infusion every 4 weeks followed by 90 mg Aredia (pamidronate) in 250 ml normal saline 2 h infusion every 4 weeks.

Intervention type

Drug

Phase

Phase II

Drug names

Zoledronate, Aredia

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1995

Overall trial end date

31/01/1998

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged >18 years
2. Histologically confirmed diagnosis of breast cancer
3. At least one osteolytic lesion which measures at least 1 cm in diameter which has not been treated with radiation therapy in the 3 months prior to the start of treatment
4. Metastatic bone lesions confirmed by plain films
5. Life expectancy of at least 10 months
6. Performance status (Eastern Cooperative Oncology Group [ECOG]) of 1-2
7. Satisfactory haematological and blood chemistry values
8. No previous continuous treatment (> four doses) with a bisphosphate, or treatment with a bisphosphate within 3 months of the start of treatment. Treatment with another bisphosphate is not allowed at any time during the trial.
9. Patients for whom orthopaedic surgery to bone or radiation therapy to bone is currently scheduled to treat skeletal disease related to metastatic bone lesions may not enter the trial. A previous history of such procedures is permitted only if the procedure was completed more than 2 weeks prior to the start of treatment
10. Patients who develop hypercalcaemia may be treated with a standard therapy other than a bisphosphate and remain on the trial
11. No recent treatment with cacitonin, mitharmycin or gallium nitrate
12. No previous history of allergic reactions or sensitivity to bisphosphates
13. Normal electrocardiogram (ECG)

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

01/01/1995

Recruitment end date

31/01/1998

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

http://www.cancer.org.uk

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

Publication citations

Additional files

Editorial Notes