| Source of record | UK Trials |
| ISRCTN | ISRCTN52623943 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICCG/10/92 |
| Public title | High Dose Therapy in Poor-Risk Primary 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. Complete prior resection of tumour and axillary node clearance
2. Histologically proven T1-T4 primary breast cancer with at least four involved nodes in the axilla
3. Adequate local therapy as defined in the protocol
4. Aged <60 years
5. No previous malignancy or evidence of metastatic disease
6. Fit to receive treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 28/09/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Regimen A: Chemotherapy, 5-fluorouracil, epirubicin and cyclophosphamide (FEC), one 3 week cycle, then FEC repeated every 4 weeks for five cycles.
2. Regimen B: Chemotherapy, FEC one 3 week cycle, then FEC repeated every 4 weeks for five cycles followed by high dose therapy with cyclophosphamide, thiotepa and carboplatin and peripheral blood stem cell support. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Amgen |
| Sponsor name | Amgen Limited |
| Sponsor details | 240 Cambridge Science Park
Cambridge
United Kingdom
CB4 4WD |
| Sponsor telephone | +44(0)1223 420305 |
| Sponsor fax | +44(0)1223 423049 |
| 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 | ISRCTN52623943 |
| Date last extracted from ISRCTN register | 17/04/2008 |
