| Source of record | UK Co-ordinating Committee on Cancer Research (UKCCCR) |
| Serial number at source | B26 |
| Title of trial | A United Kingdom Multicentre Randomised Trial of Hormono Chemotherapy for Early Poor risk Breast Carcinoma |
| Disease or condition | Breast |
| Current status of trial | Closed |
| Objectives | To determine whether adjuvant therapy given in early poor risk breast carcinoma patients will increase the disease free interval and improve survival. |
| Eligibility criteria | 1. Aged < 70 years.
2. Operable carcinoma of the breast with no fixity to pectoral fascia and/or muscle and no extensive skin infiltration (stages T1a, T2a, T3a).
3. Histological proof of lymph node involvement (stage N1).
4. No distant metastases.
5. No previous treatment for any malignant disease, except squamous cell carcinoma of the skin or carcinoma in situ of the cervix adequately treated.
6. Adequate bone marrow and liver function.
7. No medical contraindications to treatment protocols. |
| Randomised interventions | Primary treatment is a combination of surgery and radiotherapy aimed at eradicating the local and regional disease followed by randomisation to one of the following groups:
1. Arm A:
Control - no further treatment.
2. Arm B:
Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil. The initial eight cycles are to be given intravenously at three weekly intervals followed by sixteen cycles to be given orally at four weekly intervals.
3. Arm C:
Tamoxifen 20mg twice daily for two years.
4. Arm D:
Tamoxifen 20mg twice daily for two years plus chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil. The initial eight cycles of chemotherapy are to be given intravenously at three weekly intervals followed by sixteen cycles to be given orally at four weekly intervals. |
| Sponsor | Cancer Research Campaign,ICI Pharmaceuticals,Lederle Laboratories,Roche Pharmaceuticals |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
LONDON NW1 2DA
Tel: +44 (0) 20 7670 4723
Fax: +44 (0) 20 7670 4818
|
| Further information | Further information about this trial may be obtained from UKCCCR Register's own website, which contains full trial reports. |
| General information | Please visit the UKCCCR Register website for further general information. |
| Date live in mRCT | 01 April 2007 |
