The Clinical Trials Group has a long history of running clinical trials; there follows a brief summary of some of the more important studies.
Cancer Research Campaign (Kings/Cambridge) Trial
This trial was launched in 1970 to determine whether patients with early breast cancer would benefit from post operative radiotherapy following mastectomy compared to watch policy alone. Two thousand eight hundred patients were entered from five countries in five years. The original major analysis confirmed a statistically significant benefit, in terms of local control and survival, for patients receiving post-operative radiotherapy and this has since been widely accepted into standard practice. In 1986 a further analysis revealed a possibility of patients in the radiotherapy group showing an increase in deaths due to cardiac problems. The radiotherapy data were analysed in depth to determine whether the radiotherapy techniques of the time could have caused long term radiation damage to the heart.
Nolvadex Adjuvant Trial Organisation (NATO) Trial
The NATO was a large trial of adjuvant tamoxifen versus control in early breast cancer. This trial was instrumental in establishing the benefit of adjuvant tamoxifen. The project was the joint responsibility of ICI (now AstraZeneca) and a consortium of clinicians (The Nolvadex Adjuvant Trial Organisation). Data monitoring during the accrual period was carried out by ICI, then transferred to our group for continued follow-up.
Cancer Research Campaign Adjuvant Breast Trial
The CRC2 Trial was a large multicentre study of adjuvant tamoxifen and a short course of perioperative chemotherapy. It further substantiated the benefit of tamoxifen.
This trial was intended to test whether tamoxifen alone might offer similar results to surgery plus tamoxifen in elderly women with operable breast cancer. The trial was begun in 1984 and had randomised 455 when it closed in 1992.
CRC Adjuvant Breast Trial for Patients Over the Age of Fifty
This randomised, multicentre trial was launched in 1986 addressing the question of duration of tamoxifen treatment. At that time most patients were prescribed two years of treatment. The trial was planned to be large and pragmatic in design to evaluate the policy of giving a longer duration (five years) of tamoxifen therapy. The major end points of the study were length of event-free survival and length of overall survival. The original accrual target of 3000 randomised patients was revised by the Working Party and increased to 4000 patients due to a lower than anticipated event rate. A total of 6979 patients from oncology departments of 71 participating hospitals in UK, Belgium, Poland and Hong Kong were registered in the trial until February 1997 (trial closure). Of these 3979 patients were randomised in the trial. The results from this trial provided a major contribution in the attempts to clarify the question of optimum tamoxifen duration.
CRC Radiotherapy Trial for the treatment of women with early breast cancer: the role of radiotherapy
This randomised, pragmatic trial was launched in 1986 to evaluate further the role of radiotherapy in women with early, operable breast cancer receiving adjuvant systemic therapy. The need for such a trial has arisen due to the considerable changes in the management of breast cancer during the last decade. Local excision and systemic adjuvant treatment are now established components in the treatment of early breast cancer. Therefore it was deemed necessary to redefine the role of irradiation in the current management regimens. The main endpoints of the study were local recurrence and to a lesser extent overall survival. A total number of 585 patients were entered by 26 clinicians at 20 hospitals in the UK. In March 1995 the trial was closed early on recommendation of the Data Monitoring Committee (DMC). Adjuvant radiotherapy clearly reduced the risk of loco-regional recurrence of breast cancer (RR=0.36; 95% CI (0.23 - 0.57); median follow-up (live patients) of 3.4 years), which confirmed the continuing role of radiotherapy in the treatment of early breast cancer.
ATAC-Arimidex, Tamoxifen Alone or in Combination
ATAC was a novel collaboration between a pharmaceutical company, Zeneca (now AstraZeneca), and some of the leading breast cancer research groups around the world. Our Group played a pivotal role in running this study, and in the subsequent LATTE Study (Long-term Anastrozole and Tamoxifen Treatment Effects).
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