Skip to main content

Table 1 Inclusion and exclusion criteria for participation in the study

From: Pilot phase III immunotherapy study in early-stage breast cancer patients using oxidized mannan-MUC1 [ISRCTN71711835]

Criteria Details
Inclusion Postmenopausal women (no menstrual period for >12 months)
  Histological proven adenocarcinoma of the breast treated primarily by modified radical or partial mastectomy and axillary dissection followed by radiotherapy of the residual breast
  No more than four ipsilateral lymph nodes with metastases, not extending into the surrounding tissue and surgical margin free from disease
  Tumor tissue positive for oestrogen receptor
  Tamoxifen 20 mg/day commencing within 3 months of breast surgery and to continue for 5 years (provided by A. Dervos – G Dimitrakopoulos &Co OE)
  Adequate bone marrow function (white blood cell count >4.0 × 109/l, haemogoblin >100 g/l, platelet count >100 × 109/l)
  Adequate liver function (billirubin <60 μmol/l [that is, under three times the upper limit of normal)
  Adequate renal function (creatinine <140 μmol/l)
  Life expectancy >12 weeks
  ECOG (Eastern Cooperative Oncology Group) status between 0 and 2 (In bed <50% of daytime)
  Written informed consent by the patient.
Exclusion criteria Known metastatic breast cancer
  Radiotherapy, chemotherapy, immunotherapy, or investigation therapy within the preceding four weeks
  Previous splenectomy or radiotherapy to spleen
  Coexisting or previous other malignancies except in situ carcinoma of the cervix or basal cell carcinoma of the skin
  Active uncontrolled infection
  Psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in or to comply with the requirements of the study
  Concurrent systematic corticosteroid treatment
  Autoimmune disease (that is, rheumatoid arthritis, systematic lupus erythematosus; except autoimmune thyroiditis)