| Source of record | UK Trials |
| ISRCTN | ISRCTN62673495 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | BR9405 |
| Public title | Prospective Randomised Evaluation of High-Intensity Chemotherapy with Peripheral Blood Progenitor Support in Patients with High Risk Breast Cancer |
| Scientific title |
|
| Acronym | N/A |
| 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. Aged >18 years (usually <55 years).
2. Histologically proven operable stage II or IIIA breast cancer with an involvement of at least four lymph nodes
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Confirmed normal haematological and biochemical parameters
5. Free from overt metastatic disease
6. No other malignancy, except basal cell carcinoma of the skin or in-situ carcinoma of the cervix
7. Fit to receive treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 30/06/1999 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. High Dose Arm: Induction chemotherapy with single agent doxorubicin (adriamycin), treatment to be repeated every 3 weeks for four cycles. Induction chemotherapy to be followed by high dose chemotherapy, cyclophosphamide then cyclophosphamide and thiotepa, with stem cell support.
2. Conventional Arm: Induction chemotherapy with single agent doxorubicin, treatment to be repeated every 3 weeks for four cycles followed by conventional cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 3 weeks for eight cycles. |
| 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 | ISRCTN62673495 |
| Date last extracted from ISRCTN register | 17/04/2008 |
