Status:
COMPLETED
Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
Lead Sponsor:
Eric Winer, MD
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 posit...
Detailed Description
Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00148668
Start Date
December 1 2003
End Date
August 1 2011
Last Update
April 9 2013
Active Locations (4)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06520
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115