Open Label Phase I Combination Trial of BIBW 2992 and Herceptin in Patients With Refractory Breast Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms
Female
Breast Neoplasms
Trial Information
Open Label Phase I Combination Trial of BIBW 2992 and Herceptin in Patients With Refractory Breast Cancer
Inclusion Criteria
Inclusion criteria:
1. Female patients aged >18 years.
2. 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary endpoint of this study will be the Maximum Tolerated Dose of BIBW 2992 given in combination with Herceptin®.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Boehringer Ingelheim
Investigator Role:
Study Chair
Investigator Affiliation:
Boehringer Ingelheim Pharmaceuticals
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
1200.68
NCT ID:
NCT00950742
Start Date:
August 2009
Completion Date:
May 2013
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
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