Trial Information

A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer

Before starting treatment, a clip will be placed via catheter into the tumor bed, so the
surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be
taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will
be performed.

Patients will be placed into one of 2 arms.

- Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of
taxotere/carboplatin/herceptin.

- Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each
cycle.

Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a
second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on
week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place
a minimum of 3 weeks after the patients last dose of herceptin and navelbine.

Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and
second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on
week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will
take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and
carboplatin.

Blood tests will be performed every 3 weeks during pre-operative treatment and every 6
months after surgery.