Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00136539
• Lead Sponsor: Harold J. Burstein, MD, PhD

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-03
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-29
• Primary Completion: 2006-11
• Study Completion: 2012-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery

Secondary Outcome Measures

Name	Time	Method
To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy	3 years

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States