Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
The purpose of this study is to find out what effects the preoperative combination therapies
 of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with 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.
Inclusion Criteria:

 -  Patients with stage II or III breast cancer

 -  HER-2 positive tumors

 -  Older than 18 years of age

 -  Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.

 -  ANC > 1,500/mm3

 -  Hemoglobin > 9gm/dl

 -  Platelets > 100,000mm3

 -  Creatinine < 2mg/dl

 -  Glucose < 200mg/dl

 -  Bilirubin < 1.5 x ULN

 Exclusion Criteria:

 -  Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type
 therapy, navelbine, or platinum-based therapy.

 -  Pregnant or breast-feeding women

 -  Serious illness, or medical or psychiatric condition

 -  Uncontrolled infections

 -  Active or severe cardiovascular or pulmonary disease

 -  Patients with left ventricular ejection fraction < 50%

 -  Peripheral neuropathy of any etiology that exceeds grade 1

 -  Prior history of malignancy

 -  Uncontrolled diabetes