Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer

Phase 2

Completed

Interventions: Drug: Herceptin
Drug: Taxotere
Drug: Navelbine
Drug: Carboplatin

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm 1	Herceptin	Herceptin/navelbine
Arm 2	Herceptin	Taxotere/carboplatin/herceptin
Arm 2	Taxotere	Taxotere/carboplatin/herceptin
Arm 1	Navelbine	Herceptin/navelbine
Arm 2	Carboplatin	Taxotere/carboplatin/herceptin

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer	12 weeks	Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery

Secondary Outcome Measures

Name	Time	Method

Locations (4): Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Yale Cancer Center
🇺🇸
New Haven, Connecticut, United States