Status:
COMPLETED
Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.
Detailed Description
Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant chemotherapy has a number of potential advantages including increasing the chances for breast preservation a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Female patient ≥ 18 years of age
- Histologically proven stage II or III adenocarcinoma of the breast
- Must be candidate for neoadjuvant treatment (Tumor size ≥ 2 cm, T2, T3, T4 and/or clinical N1 or N2).
- HER-2/neu 1+ or 2+ by immunohistochemistry
- Must have operable tumor.
- Performance status of 2 or better per SWOG criteria
- LVEF ≥ 55% by echocardiogram performed within 4 weeks prior to treatment initiation
- If patient of childbearing potential, pregnancy test is negative
- Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.
- Adequate bone marrow function: ANC \> 1500/mm3, platelet count \> 100,000/mm3, and hemoglobin \> 9 g/dL
- Adequate kidney function: serum creatinine of \< 1.5mg/dl and/or creatinine clearance of \> 60 mL/min
- Adequate hepatic function: transaminases \< 2.5 x upper limit of normal and total bilirubin \< 1.5 mg/dL
- Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.
- Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration.
- EXCLUSION CRITERIA:
- Patient with metastatic breast cancer.
- Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry
- Women with HER 2 FISH amplified tumors (FISH ratio \>2.2)
- Patients who have had prior endocrine therapy for \> 4 weeks or chemotherapy for this breast cancer will be excluded.
- Locally advanced, inoperable tumors will be excluded.
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.
- History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
- Ejection fraction \< 55%
- Pregnancy or lactation
- Patients with inadequate laboratory values (as defined above) are excluded from study.
- Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.
- Patients with active infection are excluded from study.
- Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).
- Patients with emotional limitations are excluded from study.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00944047
Start Date
July 1 2009
End Date
August 1 2017
Last Update
April 23 2018
Active Locations (2)
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1
Hays Medical Center
Hays, Kansas, United States, 67601
2
University of Kansas Medical Center Cancer Center
Kansas City, Kansas, United States, 66205