Status:
WITHDRAWN
CETRA: Neoadjuvant Caelyx and Trastuzumab in Her-2 Positive Breast Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Breast Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the rate of pathologic complete response when giving docetaxel and trastuzumab followed by caelyx (liposomal doxorubicin), cyclophosphamide and trastuzumab bef...
Detailed Description
Chemotherapy in association with trastuzumab, a monoclonal antibody, given before surgery, has been shown to reduce tumor size and permit better resection of HER-2 positive breast cancers. This study ...
Eligibility Criteria
Inclusion
- Histological diagnosis of breast cancer
- Stage II-IIIB (T0-1-2-3-4-N+-M0 or T2-3-4-N0-M0; according to TNM AJCC classification, 2002)
- Hyperexpression of HER-2/neu (HercepTest 3+ or positive FISH test)
- Age\> 18 e \< 65 years
- Left ventricular ejection fraction (LVEF) \> or = 55%
- ECOG Performance Status 0-2
- Neutrophils \> or = 2000/mm³, platelets \> or = 100.000/mm³ , hemoglobin \> or = 10 g/dl), GOT, GPT and bilirubin \< 1.25 x the upper normal limit, creatinine \< 1.25 x the upper normal limit.
- Life expectancy \> 3 months
- Signed informed consent.
Exclusion
- Any prior treatment for breast cancer
- Metastatic disease (M1)
- Performance status (ECOG) \> or = 3
- Current malignancy or history of prior malignancy within past 10 years (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ of the uterine cervix)
- Neutrophils \< 2.000/mm³ , platelets \< 100.000/mm³ , hemoglobin \< 10 g/dl.
- Creatinine \> 1.25 x the upper normal limit
- GOT and/or GPT and/or bilirubin \>1.25 x the upper normal limit.
- Concomitant conditions that, in the investigator's opinion, contraindicate the use of the drugs in the protocol.
- Congestive heart failure or history of congestive heart failure, unstable angina pectoris, myocardial infarction, clinically significant valvulopathy or uncontrolled arrhythmias
- Active infection
- Incapacity or refusal to provide informed consent.
- Inability to comply with follow up
- Pregnant or nursing females.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00434031
Start Date
September 1 2007
Last Update
July 30 2012
Active Locations (1)
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1
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131