Breast Cancer Clinical Trial

Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT00136539

Recruitment Status:

Completed

Sponsor:

Harold J. Burstein, MD, PhD

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There is 1 Location for this study

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Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Massachusetts General Hospital
Boston Massachusetts, 02115, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT00136539

Recruitment Status:

Completed

Sponsor:


Harold J. Burstein, MD, PhD

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