Clinical trial · Interventional
Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer
Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression
- 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)
One important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new anticancer agents devoid of clinical cross-resistance. The possibility of exploiting the combined use of cetuximab and trastuzumab represents an option of potential great impact on the probability of response and long-term therapeutic results for patients with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2 overexpression (+ or 2+) will be included in the study. Patients will be treated with trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction of both antibodies as well as the safety and tolerability of this novel combination treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pharmacokinetics and drug/drug interaction of cetuximab and
- timeFrame
- repeated PK measurements week 1-13
Secondary outcomes (2)
- measure
- Safety and tolerability of the combination treatment
- timeFrame
- week 1 -13
- measure
- Response
- timeFrame
- week 9 and 13
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of metastatic breast cancer * presence of at least 1 measurable lesion according to modified RECIST criteria * Evidence (fluorescence in situ hybridization FISH) of * Her-2 overexpression in tumor tissue:Group A: Her-2 +++, Group B: Her-2 + or ++ * EGFR-expressing disease as assessed by immunohistochemistry * Recovered from relevant toxicities from other treatment prior to study entry Exclusion Criteria: * Prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed) * Prior treatment with cetuximab * Concomitant cytotoxic chemotherapy * Treatment with any investigational agent(s) within 4 weeks prior to study entry * Known allergic/hypersensitivity reaction to any of the components of study treatments * severe dyspnea * Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment * History of significant neurologic or psychiatric disorders
References
Publications (0)
Data not yet available