Phase 1
Completed N=13
Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.
Source: ClinicalTrials.gov NCT01649271 ↗Enrolled (actual)
13
Serious AEs
61.5%
Results posted
Nov 2017
Primary outcomePrimary: MTD of Afatinib in Combination With Trastuzumab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib). — 20 mg
Summary
The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2 overexpressing metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MTD of Afatinib in Combination With Trastuzumab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib). |
20 | — |
| PRIMARY Dose Limiting Toxicities During cycle1 |
1; 2 | — |
| SECONDARY Best Overall Response (BOR) |
0.0; 0.0; 16.7; 0.0; 16.7; 100.0 | — |
| SECONDARY Objective Response |
16.7; 0.0 | — |
| SECONDARY Clinical Benefit |
33.3; 100.0 | — |
Eligibility Criteria
Inclusion criteria
- Patients aged 18 years and older
- Patients with cancers overexpressing HER2 by Immunohistochemistry test( IHC) 3+ and/or IHC 2+ with positive gene amplification by FISH (confirmation on archived tissue needed)
- Written informed consent that is consistent with ICH-GCP guidelines.
- Patients must be eligible for treatment with trastuzumab.
- Patients must have adequate organ function (kidney, liver, bone marrow, cardiac)
- Eastern Cooperative Oncology Group (ECOG) = 0 or 1.
- Measurable disease according to RECIST 1.1 (Phase Ib).
Exclusion criteria
- Active brain metastases.
- Prior treatment with erbB family targeting therapies within the past four weeks before start of therapy or concomitantly with the trial other than trastuzumab and/or lapatinib.
- Patients having more than 2 lines of chemotherapy for the treatment of metastatic breast cancer (Phase Ib).
Data sourced from ClinicalTrials.gov (NCT01649271). 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.