Status:
COMPLETED
Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
Odense University Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients wit...
Detailed Description
Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. N...
Eligibility Criteria
Inclusion
- pathologically proven breast cancer
- inflammatory, locally advanced breast cancer or a tumor \> 5 cm
- ECOG performance status \< 2
- LVEF \> 50% measured by MUGA (HER2 positive patients)
- adequate bone marrow, liver and renal function
- written informed consent must be obtained
Exclusion
- another malignancy within 5 years prior to study entry
- concurrent treatment with an investigational agent
- other disease or condition that contraindicates participation in the study
- pregnant or lactating females
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01206881
Start Date
March 1 2009
End Date
June 1 2011
Last Update
July 4 2011
Active Locations (4)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200
2
Rigshospitalet
Copenhagen, Denmark, 2100
3
Herlev Hospital
Herlev, Denmark
4
Odense University Hospital
Odense, Denmark, 5000