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| An adjuvant randomised study comparing standard dose FE[50]C with a higher dose FE[75]C and evaluating the additional benefit of sequential hormone therapy in node positive pre-menopausal primary breast cancer |
| Source of record | UK Trials |
| ISRCTN | ISRCTN98335268 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICCG/9/91 |
| Public title | An adjuvant randomised study comparing standard dose FE[50]C with a higher dose FE[75]C and evaluating the additional benefit of sequential hormone therapy in node positive pre-menopausal primary breast cancer |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Breast cancer |
| 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 non-metastatic breast cancer 2. Received optimal axillary node sampling (at least seven nodes must be in the axillary dissection) 3. Between one and five histologically involved axillary nodes 4. Pre-menopausal that is: a. Last menstrual period within one year of randomisation, or b. Oestrogen and Follicle Stimulating Hormone (FSH)/Luteinising Hormone (LH) levels compatible with ovarian function, particularly if the patient has had a hysterectomy 5. Adequate renal, hepatic and haematological function 6. No bilateral malignancy 7. No inflammatory breast carcinoma 8. No clinically positive contralateral axillary or supraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumour 9. No ulceration or infiltration of the skin 10. No satellite breast or parasternal nodules 11. No oedema of the arm 12. No medical contraindications to treatment protocols |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Regimen A: chemotherapy, FE[50]C repeated every three weeks for eight cycles followed by hormonal manipulation. 2. Regimen B: chemotherapy, FE[50]C repeated every three weeks for eight cycles. 3. Regimen C: chemotherapy, FE[75]C repeated every three weeks for eight cycles followed by hormonal manipulation. 4. Regimen D: chemotherapy, FE[75]C repeated every three weeks for eight cycles. Patient's menopausal status to be assessed post chemotherapy. Pre-menopausal patients randomised to receive hormonal manipulation are to receive a long acting Gonadotrophin Releasing Hormone (GnRH), goserelin or equivalent, every 28 days for three years. Post-menopausal patients randomised to receive hormonal manipulation are to receive tamoxifen 20 mg daily for three years. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Pharmacia and Upjohn |
| Sponsor name | Pharmacia Ltd (UK) |
| Sponsor details | Davy Avenue Milton Keynes United Kingdom MK5 8PH |
| Sponsor telephone | +44 (0)1908 661101 |
| Sponsor fax | +44 (0)1908 690091 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.pharmacia.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 | ISRCTN98335268 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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