Table 3

Intraductal protocol for clinical trial. Three women were enrolled in a vehicle-only cohort (dose level 0) to establish study logistics and local adverse events with the vehicle alone. The dose levels tested included 2, 5, and 10 mg of PLD per duct corresponding to levels 1, 2, and 3. The number of attempted procedures and adverse events is summarized.

Dose levelPLD dose (mg),
in 5 ml of dextrose
Ductal cannulation
(attempted/successful)
Adverse events (mild)
Breast fullnessBreast
or nipple pain/discomfort
003/33/32/3
124/3*3/33/3
254/3†2/33/3
3106/61/66/6
Total17/159/15 (60%)14/15 (93%)

*One duct was cannulated successfully; however, PLD could not be instilled, likely owing to extensive disease (4.5-cm tumor, grade III, with one of three positive lymph nodes).

†Cannulation was not successful in bilateral breasts, likely owing to previous excisional biopsies.