Status:
COMPLETED
Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer
Lead Sponsor:
Prof Dirk Elling
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with * Non-pegylated lipos...
Detailed Description
Breast cancer is the most common malignancy affecting females in northern Europe and North America, corresponding to an age-corrected annual incidence of 100 to 120 per 100000 females. Approximately 3...
Eligibility Criteria
Inclusion
- Histologically confirmed breast cancer
- T1c N1-2 or T2 N0-2 disease
- HER2-positive tumours with 3+ intensity on immunohistochemical staining for HER2 or amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
- No prior systemic treatment regimens for breast cancer
- Adequate hematologic function (ANC 1500 cells/µl, platelet count 100000/µl, and hemoglobin 8g/dl).
- Serum creatinine concentration \< 1.5 times the upper limit of normal (ULN) and/or creatinine clearance \>60 ml/min
- Bilirubin level \< 1.5 X ULN
- Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram or MUGA scan)
- Karnofsky performance status 80%
- Age 18 years
- If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry
- Written informed consent prior to admission to this study
Exclusion
- Male patients
- Inflammatory or bilateral breast cancer
- Evidence of distant metastases
- Previous systemic or local treatment for breast cancer (including surgery, radiotherapy, cytotoxic and endocrine treatments)
- Past or current history of other neoplasms, except for
- Curatively treated non-melanoma skin cancer
- Adequately treated in situ carcinoma of the cervix
- Other cancer curatively treated and with no evidence of disease for at least 5 years
- Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure \>115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy
- Preexisting sensoric or motor polyneuropathy Grade 2 according to NCI CTC
- Serious intercurrent medical or psychiatric illness, including serious active infection
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
- Detained persons or prisoners
- Pregnant or nursing women
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01172223
Start Date
September 1 2007
End Date
December 1 2013
Last Update
November 2 2016
Active Locations (1)
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1
Sana Klinikum Lichtenberg
Berlin, Germany