Status:
COMPLETED
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilo...
Eligibility Criteria
Inclusion
- women \>=18 years;
- locally advanced or metastatic breast cancer;
- HER-2 overexpression (FISH + or IHC 3+);
- \>=1 measurable lesion;
- up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.
Exclusion
- pre-existing neuropathy \>=grade 2;
- known CNS metastases;
- congestive heart failure, or myocardial infarction within the last 6 months;
- previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00337649
Start Date
May 1 2004
End Date
July 1 2007
Last Update
April 28 2023
Active Locations (6)
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1
Barcelona, Spain, 08035
2
Barcelona, Spain, 08036
3
Barcelona, Spain, 08041
4
Madrid, Spain, 28041