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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Herceptin
* Drug: Navelbine
* Drug: Taxotere
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Herceptin/navelbine | Drug: Herceptin<br>* One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.<br>* Other names: Trastuzumab;Drug: Navelbine<br>* Weekly injections given starting week 3 and ending week 14<br>* Other names: vinorelbine;|
| Active Comparator: Arm 2<br>Taxotere/carboplatin/herceptin | Drug: Herceptin<br>* One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.<br>* Other names: Trastuzumab;Drug: Taxotere<br>* Given every three weeks starting week 3 and ending on week 14<br>* Other names: docetaxel;Drug: Carboplatin<br>* Given every three weeks starting week 3 and ending on week 14<br>* Other names: paraplatin;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER-2 Positive Breast Cancer, herceptin, navelbine, taxotere, carboplatin, Early stage Breast Cancer