Status:
COMPLETED
Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Female patients aged \>18 years.
- Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.
- Exclusion criteria:
- Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00950742
Start Date
August 1 2009
End Date
October 1 2013
Last Update
February 10 2025
Active Locations (5)
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1
1200.68.44001 Boehringer Ingelheim Investigational Site
Brighton, United Kingdom
2
1200.68.44003 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
3
1200.68.44005 Boehringer Ingelheim Investigational Site
Guildford, United Kingdom
4
1200.68.44004 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, United Kingdom