Surgery Studies

Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer (1703386)

The trial will be offered to patients who have just been diagnosed with early breast cancer and who are planned to have surgery in the next few weeks. The treatment will bridge the time between the diagnosis and surgery and will be given for 2- 4 weeks. To assess the effect of the treatment, small samples of breast cancer tissue will be analysed before the start and after treatment. The pre-treatment assessment will be done on archived tissue but patients might require an additional biopsy, if sufficient stored tumour tissue is not available. The end of treatment samples will be taken during surgery, unless the patient will receive medical treatment first instead of surgery which might mean additional biopsies of the breast cancer have to be taken.

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer (1607266)

This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal women with ER-positive/HER2-negative breast cancer.

POSNOC (1610317)

POSNOC – POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomised controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes.

Hartmann’s procedure versus intersphincteric APE: a prospective study (1608296)

More than 41 000 new cases of bowel cancer are diagnosed annually in the UK with one third occurring in the rectum. Standard treatment for rectal cancer is an operation that removes the section of bowel containing the tumour, reconnecting healthy bowel to the anal canal. This reconstructive approach allows patients to defecate normally, but is associated with a relatively high rate of perioperative complications (40%) and poor bowel function (50%). Where these risks are unacceptably high (frail patients, multiple comorbidities, poor pelvic floor/anal canal function) alternative non-reconnecting strategies are substituted.

Hartmann’s procedure (HP) has been regarded as the non-reconnecting operation of choice and is technically quite straightforward. Alternatively, another operation called IAPE completely removes all of the rectum and anal canal which is thought to significantly reduce the incidence of serious pelvic infection that may with HP. Some surgeons are reluctant to perform this procedure due to the slightly increased operating time and the risk of the local wound failing to heal.