Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00136539

Run by

Harold J. Burstein, MD, PhD

People needed

41

Starts

1999-03-01

Expected to finish

2012-03-01

Last updated by the study team

2013-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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