Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Sponsor

Harold J. Burstein, MD, PhD (Other)

Overall Status

Completed

CT.gov ID

NCT00136539

Collaborator

Dana-Farber Cancer Institute (Other), Genentech, Inc. (Industry), Bristol-Myers Squibb (Industry), Massachusetts General Hospital (Other), Beth Israel Deaconess Medical Center (Other), Harvard Vanguard Medical Associates (Other), Brigham and Women's Hospital (Other)

Enrollment

Locations

156

Duration (Months)

20.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Herceptin Drug: Taxol Drug: Adriamycin Drug: Cytoxan	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 1999

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Mar 1, 2012

Outcome Measures

Primary Outcome Measures

To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery []

Secondary Outcome Measures

To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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