Status:
COMPLETED
Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years
Lead Sponsor:
Asociación para el Progreso de la Oncología en Málaga
Collaborating Sponsors:
Roche Farma, S.A
Conditions:
HER-2 Positive Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Main objective: To analyze the clinical and biological characteristics of patients with disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete remission, partial or s...
Detailed Description
SECONDARY OBJECTIVES: * To determine the frequency of patients achieving partial response or stable disease for a period exceeding 3 years. * Know the time to complete or partial remission or to achi...
Eligibility Criteria
Inclusion
- Women older than 18.
- Patients with disseminated breast cancer with overexpression of HER-2 (IHC 3 + or FISH +).
- Patients who have been treated with trastuzumab (Herceptin ®).
- Complete remission, partial or stable disease for a period exceeding 3 years, except for exclusive cerebral progression.
- Patients who have given their written informed consent.
Exclusion
- 1- Patients with remission achieved with surgery or less than three months of treatment with trastuzumab.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01433926
Start Date
September 1 2009
End Date
September 1 2011
Last Update
September 14 2011
Active Locations (39)
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1
Hospital oncológico de Galicia
A Coruña, A Coruña, Spain, 15003
2
Hospital de Alcoy Virgen de los Lirios
Alcoy, Alicante, Spain, 03804
3
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain, 07198
4
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916