Clinical trial · Interventional
Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer
Phase II Clinical Study Combining Trastuzumab With Etoposide in Treatment of HER2-Positive Metastatic Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to difficulty in accruing patients
Summary
Brief summary (as posted)
This study is for women and men who have previously treated metastatic (has spread to other parts in the body), Her2- positive breast cancer. The purpose of this study is to find out what effects (good and bad) the FDA-approved drugs etoposide and trastuzumab have on this type of breast cancer and to determine if these drugs are safe to use together. This research is being done to find more effective treatment for this type of condition. In this study, trastuzumab and etoposide will be given by intravenous infusion (IV; through a vein) on the first 3 days of every 3-week cycle. This is repeated for 6 cycles. After 6 cycles, only trastuzumab will be given until worsening of disease. In this study, a small amount of your tissue that was collected when you had surgery will be evaluated in the lab to look at genetic differences among people and how those differences may affect a response to a specific drug or medicine. This testing will look for a gene called Top2A. Previous studies suggest that people who have both the Top2A and Her2 genes respond to certain chemotherapies (anti-cancer drugs) differently from those who only have the Her2 gene.
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 |
|---|---|---|---|
| HER-2 Positive Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide | Drug | Etoposide | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm study
- description
- Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression
- interventionNames
- Drug: Etoposide
- Drug: Trastuzumab
Primary outcomes (2)
- measure
- To Determine ORR of Trastuzumab Combined With Etoposide in Patients With HER2 Positive Metastatic Breast Cancer, and to Assess Toxicity of the Combination of Trastuzumab With Intravenous Etoposide.
- timeFrame
- The best overall response is the best response recorded from the start of first treatment until the date of first progression or date of death from any cause whichever came first, assessed up to 24 months
- description
- To determine the overall response rate
- measure
- To Determine Efficacy of Trastuzumab Combined With Etoposide in Patients With HER2-positive Metastatic Breast Cancer, and to Assess Toxicity of the Combination of Trastuzumab With Intravenous Etoposide.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females or males with histologic confirmation of breast carcinoma and diagnosis of metastatic breast adenocarcinoma * Confirmed HER2 amplification by immunohistochemical staining (IHC) 3+ or FISH amplified (either primary or metastatic). * Have had any number of prior HER2 targeted therapy containing chemotherapies for treatment of breast cancer * Measurable extent of disease * Life expectancy of 3 months or greater * Patients must have adequate heart function, determined with ECHO or MUGA (ECHO preferred). * Patients must have adequate bone marrow and organ function * Patient of childbearing potential must be willing to use an effective means of contraception during their participation on trial * Greater than 3 weeks from prior radiation or chemotherapy; more than 1 week from prior hormonal therapy; and more than 6 weeks from prior treatment with nitrosoureas or mitomycin. * No serious intercurrent medical illness. * Controlled metastatic CNS disease ≥ 3 months * The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. Exclusion Criteria: * Pregnant or nursing women * Patients who are poor medical risk because of other non-malignant systemic disease or active, uncontrolled infection. * Prior craniospinal radiation, or total body irradiation (TBI). * Patients receiving G-CSF (filgrastim or pegfilgrastim) or thrombopoietin (or other platelet growth factors) within the 3 weeks prior to enrollment (erythropoietin is allowed). * Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin). * Prior radiation therapy within the last 3 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation). * Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * Current symptoms of angina or uncontrolled arrhythmias, uncontrolled hypertension with systolic blood pressure \>=170 or diastolic blood pressure \>=110. * Psychiatric illness precluding participation in study * Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest. * Carcinomatous meningitis or CNS mets not controlled for ≥ 3 months.
References
Publications (0)
Data not yet available