Trial Information

Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer

- As part of the patients pre-treatment evaluation, a clip will be placed within the
tumor bed so that the surgeon can find it at the time of surgery. Four biopsies of the
tumor will be obtained at the time of the clip placement for further testing at a later
date.

- Depending upon the patient's risk level (as assessed by the treating physician), they
will be treated similarly to one of two regimens. The first 8 months of both regimens
are the same consisting of 12 weeks of herceptin and navelbine, followed by surgery and
then 4 cycles of adriamycin and cytoxan. The treatment following these 8 months will
depend upon the health risk to the patient and will be determined by both the patient
and treating physician.

- Group 1: Lower Risk Regimen: Patients in this group will receive 3 phases of
treatment. In Phase A they will receive Navelbine and Herceptin intravenously every
week for 12 weeks. Upon completion of this therapy they will undergo surgery to remove
the tumor. Following surgery there will be a 6 week recovery period where no treatment
will be received. In Phase B, patients will receive adriamycin (doxorubicin) and
cytoxan (cyclophosphamide) intravenously every 3 weeks for 12 weeks, for a total of 4
cycles. Patients then may or may not receive Phase C (depending upon physicians
discretion), during which they will receive herceptin intravenously every 3 weeks for
40 weeks. If the physician decides that the patient needs radiation therapy, it will
commence after the completion of adriamycin and cytoxan.

- Group 2: Higher Risk Regimen: Patients in this group will undergo four different
phases of treatment. Phase A is identical to that of Group 1 (herceptin and navelbine
for 12 weeks followed by surgery) as is Phase B (adriamycin and cytoxan every 3 weeks
for 12 weeks for a total of 4 cycles). Phase C will consist of paclitaxel and
herceptin weekly for a total of 12 weeks. If the physician decides that radiation
therapy should be performed, it will commence within 6 weeks of the last dose of
paclitaxel and herceptin. In Phase D, patients will receive herceptin intravenously
every three weeks for 28 weeks.

- The following procedures and tests will be performed during this study: During Phase
A: Every week: blood work; Every 3 weeks: physical exam, tumor assessment and
bloodwork. During Phase B: Every 3 weeks; physical exam and blood work. At the start
of Phase B and C: physical exam, EKG, MUGA scan or echocardiogram and bloodwork.
During Phase C: Every 3 weeks for High risk patients and every 3 months for low risk
patients; physical exam and blood work. End of Phase C: MUGA scan or echocardiogram.
Phase C and D: every 3 months; physical exam, EGK, MUGA scan or echocardiogram and
bloodwork.

- At the end of the study patients will undergo a physical exam, EKG, MUGA scan or
echocardiogram and bloodwork.