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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00148668

Run by

Eric Winer, MD

People needed

81

Starts

2003-12-01

Expected to finish

2011-08-01

Last updated by the study team

2013-04-09

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale Cancer Center — New Haven, Connecticut, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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