Phase 1
Completed N=18
Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
Source: ClinicalTrials.gov NCT00950742 ↗Enrolled (actual)
18
Serious AEs
16.7%
Results posted
Oct 2013
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLT) — 4; 2 Participants
Summary
Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLT) |
4; 2 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R) |
20 | — |
| SECONDARY Number of Patients With Objective Response (OR) |
2; 0 | — |
| SECONDARY Number of Patients With Best Overall Response |
0; 0; 2; 0; 4; 1 | — |
| SECONDARY Progression Free Survival (PFS) |
113.0; 83.5 | — |
| SECONDARY Summary of Concentration of Afatinib in Plasma |
9.75; 9.94; 9.15; 17.9 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) |
4.25 | — |
| SECONDARY Summary of Concentration of Herceptin in Plasma |
43600; 47200; 46200; 122000; 93000; 93200 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00950742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.