Clinical trial · Interventional
Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer
- 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 purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer. RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy. SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.
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 |
|---|---|---|---|
| Carcinoma, Metastatic Breast | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPG 7909 | Drug | — | UNRESOLVED |
| Herceptin® | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 0.01 mg/kg CPG 7909 plus Herceptin®
- interventionNames
- Drug: CPG 7909
- Drug: Herceptin®
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 0.04 mg/kg CPG 7909 plus Herceptin®
- interventionNames
- Drug: CPG 7909
- Drug: Herceptin®
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- 0.16 mg/kg CPG 7909 plus Herceptin®
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA Inclusion Criteria * Histologically confirmed breast cancer with metastases. * Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry. * Patients must be candidates for single agent Herceptin treatment according to the Herceptin® label. Exclusion Criteria * Any prior therapy with anthracycline + Herceptin®. * Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction \< 50%.
References
Publications (0)
Data not yet available