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
| ISRCTN | ISRCTN29188871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29188871 |
| Secondary identifying numbers | C120 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 09/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Zoledronate, Aredia |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1995 |
| Completion date | 31/01/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key 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) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/01/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/12/2019: No publications found. All search options exhausted.
