Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Herceptin (Drug); Taxol (Drug); Adriamycin (Drug); Cytoxan (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s):
Harold Burstein, MD, PhD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
Official title: Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery
Secondary outcome: To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02115, United States
Additional Information
Starting date: March 1999
Ending date: November 2009
Last updated: December 22, 2007
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