Clinical trial · Interventional
Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.
Phase I Trial of Afatinib in Combination With 3 Weekly Trastuzumab in Patients With Tumours Overexpressing HER2. Once the MTD of Afatinib With 3 Weekly Trastuzumab Was Established the Safety of This Dose Will be Assessed Also in Combination With Weekly Trastuzumab.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| afatinib | Drug | Afatinib | ALIAS |
| Herceptin | Drug | Trastuzumab | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase Ia, group 1
- description
- afatinib escalating dose with 3-weekly trastuzumab
- interventionNames
- Drug: Herceptin
- Drug: afatinib
- type
- EXPERIMENTAL
- label
- Phase Ia, group 2
- description
- afatinib at MTD dose with weekly trastuzumab
- interventionNames
- Drug: afatinib
- Drug: Herceptin
- type
- EXPERIMENTAL
- label
- Phase Ib
- description
- afatinib at MTD level with 3-weekly trastuzumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion criteria: 1. Patients aged 18 years and older 2. 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) 3. Written informed consent that is consistent with ICH-GCP guidelines. 4. Patients must be eligible for treatment with trastuzumab. 5. Patients must have adequate organ function (kidney, liver, bone marrow, cardiac) 6. Eastern Cooperative Oncology Group (ECOG) = 0 or 1. 7. Measurable disease according to RECIST 1.1 (Phase Ib). Exclusion criteria: 1. Active brain metastases. 2. 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. 3. Patients having more than 2 lines of chemotherapy for the treatment of metastatic breast cancer (Phase Ib).
References
Publications (0)
Data not yet available