A randomised placebo-controlled trial of epirubicin and quinidine in patients with advanced breast cancer
| ISRCTN | ISRCTN23196537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23196537 |
| Protocol serial number | B29(Scot) |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 01/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| 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 |
| Intervention | Both arms receive Epirubicin 100 mg/m^2 iv every 3 weeks for a maximum of eight doses. At each cycle patients also receive a 6-day course of capsules either Quinidine 250 mg or placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | epirubicin, quinidine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/1992 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | 1. Histologically proven metastatic or locally advanced disease 2. Measurable or evaluable disease 3. World Health Organisation (WHO) Performance status at least 2 4. Haemoglobin ≥10 g% 5. White Blood Count (WBC) >4.0 x10^9/l 6. Platelets ≥100 x 10^9/l 7. Bilirubin within normal range 8. Not currently receiving hormone treatment 9. No prior chemotherapy for advanced disease |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1988 |
| Date of final enrolment | 01/09/1992 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/1994 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
