Status:
COMPLETED
Phase II Study With Trastuzumab + Paclitaxel in Locally Advanced HER2+ Tumors or Epirubicin + Taxotere in HER2- Tumors
Lead Sponsor:
Centro di Riferimento Oncologico - Aviano
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Prospective, monoinstitutional, phase II study. Patients with HER 2 positive locally advanced breast cancer will be treated with 3 initial cycles (12 weeks) of trastuzumab plus paclitaxel and then if ...
Detailed Description
Primary Objective: to determine the pathological complete response (pCR) and correlation with immune response. Secondary Objectives: * to determine the progression free survival (PFS) and overall su...
Eligibility Criteria
Inclusion
- Histologically proven breast carcinoma evaluated for HER 2 status and immune status
- Locally advanced carcinoma (UICC stage II-III)
- Age \< 70 years
- measurable lesions
- ECOG Performance Status 0-2
- Life expectancy \> 3 months
- Adequate bone marrow and hepatic functions
- Creatinine Clearance \> 40 ml/min
- Written informed consent
- Patients must be accessible for treatment and follow up.
Exclusion
- Prior chemotherapy or hormonal treatments
- Brain metastases.
- Past or current history of neoplasm other than curatively treated.
- Concurrent treatment with other experimental drugs.
- Left Ventricular Ejection Fraction (LVEF) \<50 %
- History of significant neurological or psychiatric disorders.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02307227
Start Date
April 1 2006
End Date
April 1 2014
Last Update
December 4 2014
Active Locations (1)
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1
Centro di Riferimento Oncologico
Aviano, Pordenone, Italy, 33081