All patients who are withdrawn from the study before week 24 must be 
given a complete physical examination and tests as outlined for week 
24 should be done. The patient number must not be re-assigned to 
another patient. 
11.0 EFFICACY PARAMETERS 
11.1 Tumor Status Assessment 
11.1.1 Parameter 
The patient must have one or more measurable lesions by 
physical examination or non-invasive radiologic procedure. 
Measurable is defined as the product of two perpendicular 
diameters of marker lesions, in centimeters, applied at the 
widest portion of tumor. 
11.1.2 Frequency 
Screening and week 12. 
11.2 Tumor Response 
11.2.1 Complete response (CR) is the disappearance of all clinically 
detectable disease for a period of at least 28 consecutive days. 
11.2.2 Partial response (PR) is a 50% or greater decrease in the sum of 
the products of the two greatest perpendicular diameters of all 
measurable lesions for a period of at least 28 consecutive days. 
No simultaneous increase in the size of any lesion or 
appearance of any new lesions may occur. 
11.2.3 Stable disease (S) is a <25% increase or <50% decrease in tumor 
size as defined above throughout the period of treatment. No 
appearance of any new lesions may occur. 
11.2.4 Progressive disease (PD) is a >25% increase in tumor size. 
Appearance of new lesions will also constitute progressive 
disease. 
12.0 BIOSTATISTICS 
Survival time from the date of diagnosis of metastatic breast cancer to 
death will be measured. Also, the time from the date of initiation of 
therapy on this study to death will be measured. Efficacy variables will 
include detection of disease progression. Immune status will be 
assessed by absolute lymphocyte counts and delayed hypersensitivity 
skin tests. Specific anti-breast cancer immunity will be measured by 
appropriate breast cancer T cell assay. 
Sample size determination was based on the major endpoint of the 
study, toxicity. For this safety study, interest in this study will be 
heightened if the data indicate a toxicity rate of 5 per cent or less. 
Conversely, interest in this treatment will diminish if the data indicate 
a toxicity rate of 30 per cent or more. For this study, an unacceptable 
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