| Source of record | UK Trials |
| ISRCTN | ISRCTN52817670 |
| Date ISRCTN assigned | 15/10/2002 |
| Local reference number(s) | BR0201 |
| Public title | A randomised 2-arm, prospective, multi-centre, open-label Phase III trial comparing the activity and safety of a weekly versus a 3-weekly Paclitaxel treatment schedule in patients with advanced or metastatic breast cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically proven breast cancer
2. Locally advanced or metastatic disease
3. Presence of measurable or evaluable lesions
4. Prior treatment with anthracyclines (either in the adjuvant setting or for metastatic disease) or contra-indication to anthracyclines
5. Aged 18 years or greater
6. World Health Organisation (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status ≤2
7. Adequate haematological, renal and hepatic function
8. Written informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 16/09/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Arm 1: Paclitaxel (90 mg/m2 IV over 1 h on day 1 every week)
Arm 2: Paclitaxel (175 mg/m2 IV over 3 h on day 1 every 3 weeks) |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Anglo Celtic Cooperative Oncology Group (supported by an educational grant
from Bristol-Myers Squibb Pharmaceuticals Limited) |
| Sponsor name | Anglo Celtic Cooperative Oncology Group |
| Sponsor details | SCTN Central Office
Information & Statistics Division
Trinity Park House
South Trinity Road
Edinburgh
United Kingdom
EH5 3SQ |
| Sponsor telephone | +44 (0)131 551 8363 |
| Sponsor fax | +44 (0)131 552 4085 |
| Sponsor email | joanna.dunlop@isd.csa.scot.nhs.uk |
| Sponsor website | http://www.amgen.com |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN52817670 |
| Date last extracted from ISRCTN register | 17/04/2008 |
