| Source of record | UK Trials |
| ISRCTN | ISRCTN52689949 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | CRCBCTG9 |
| Public title | Cancer Research Campaign adjuvant breast trial for patients under 50 |
| 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. Aged < 50 years
2. Operable breast cancer, that is clinically T1,T2 or T3,N0 or N1,M0
3. No evidence of metastases
4. Normal renal, hepatic function and full blood counts, including platelets
5. Patients with bilateral tumours are not eligible
6. No concomitant hormonal therapy or chemotherapy
7. No hormonal therapy in the last 6 weeks
8. No previous malignancy, except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix adequately cone biopsied
9. Fit to receive either treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 22/03/1999 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Following surgery (local excision or mastectomy) with or without additional primary therapy patients are randomised to either:
1. Group A: No further treatment.
2. Group B: Adjuvant tamoxifen, 20 mg daily for 2 years. Treatment to start as soon as possible following surgery.
3. Group C: Zoladex, 3.6 mg depot/month for 2 years. Treatment to start as soon as possible following surgery.
4. Group D: Tamoxifen 20 mg daily and Zoladex 3.6 mg depot/month both for 2 years. Treatment to start as soon as possible following surgery. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| 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 | ISRCTN52689949 |
| Date last extracted from ISRCTN register | 17/04/2008 |
