Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Detailed Description
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Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10). After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy). Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total). After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram. At the time of surgery, re-assessment of the tumor will be done. Blood work will be performed on day one of each chemotherapy cycle.

Official Title
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Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Herceptin
* Drug: Taxol
* Drug: Adriamycin
* Drug: Cytoxan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have Stage II or III histologically diagnosed breast cancer Primary invasive breast cancers that overexpress the HER2/neu oncogene Age older than 18 years Eastern Cooperative Oncology Group (ECOG) performance status of < 1 White blood cell (WBC) > 4000/mm3 Platelet count > 100,000/mm3 Bilirubin < 1 x upper limit of normal (ULN) SGOT < 1 x ULN Creatinine < 1.5mg/dl Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy Exclusion Criteria: Excisional biopsy, sentinel node dissection or axillary node dissection. Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant. Pregnant or breast-feeding women Uncontrolled infection Active or severe cardiovascular or pulmonary disease Peripheral neuropathy of any etiology that exceeds grade 1 Prior history of malignancy treated without curative intent 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Herceptin|Given intravenously once weekly for 12 weeks prior to surgery.|
|Drug: Taxol|Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.|
|Drug: Adriamycin|Given every three weeks for 12 weeks after surgery.|
|Drug: Cytoxan|Given every three weeks for 12 weeks after surgery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Early Stage Breast Cancer, HER2-positive, HER2-positive breast cancer, Herceptin, Taxol, Stage II Breast Cancer, Stage III Breast Cancer