- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00810017
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm study
Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression
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etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles
Other Names:
intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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
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To determine the overall response rate
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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
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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.
Time Frame: From the start of first treatment until unacceptable toxicity or date of death, whichever came first, over 24 months
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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From the start of first treatment until unacceptable toxicity or date of death, whichever came first, over 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine Duration of Response
Time Frame: Stable disease is measured from the start of the treatment until the criteria for progression are met, assessed by CT scans at a minimum interval of 8 weeks over 5 years
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Stable disease
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Stable disease is measured from the start of the treatment until the criteria for progression are met, assessed by CT scans at a minimum interval of 8 weeks over 5 years
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Determine Duration of Response
Time Frame: Time to disease progression is defined as time from registration date to the date of documented disease progression or death on study, whichever occurs first for 5 years
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Time to disease progression
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Time to disease progression is defined as time from registration date to the date of documented disease progression or death on study, whichever occurs first for 5 years
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Determine Duration of Response
Time Frame: The progression-free survival rate is defined as the percentage of patients who are without disease progression while on the study treatment at the end of study, over 5 years
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The duration of overall response will be measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started.
The duration of overall CR is measured from the time measurements are met for CR until the first date that recurrent disease is objectively documented
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The progression-free survival rate is defined as the percentage of patients who are without disease progression while on the study treatment at the end of study, over 5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sandra M Swain, MD, MedStar Health Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Etoposide
- Trastuzumab
Other Study ID Numbers
- IIT_H446Us
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HER-2 Positive Metastatic Breast Cancer
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)RecruitingHER2-positive Metastatic Breast Cancer | HER-2 Protein Overexpression | HER-2 Positive Malignant Carcinoma of BreastUnited States
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Texas Tech University Health Sciences Center, El...WithdrawnBreast Cancer | Metastatic Breast Cancer | HER-2 Positive Breast Cancer | ER Positive Breast Cancer
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University of Michigan Rogel Cancer CenterGenentech, Inc.CompletedHER-2 Positive Metastatic Breast CancerUnited States
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Novartis PharmaceuticalsCompletedMetastatic Breast Cancer | HER-2 Positive Breast CancerBelgium, Netherlands, Australia, Italy, United States
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Fudan UniversityGeneQuantum Healthcare (Suzhou) Co., Ltd.RecruitingAdvanced/ Metastatic Her-2 Positive Breast CancerChina
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Ellipses PharmaRecruitingMetastatic Breast Cancer | Hormone Receptor-positive Breast Cancer | Hormone Receptor Positive HER-2 Negative Breast CancerUnited States, Spain, United Kingdom
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Adrienne G. WaksGilead SciencesRecruitingBreast Cancer Female | Breast Cancer Metastatic | Her 2 Positive Breast CancerUnited States
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Kadmon Corporation, LLCTerminatedHER-2 Positive Breast Cancer | Metastatic Malignant Neoplasm to BrainUnited States
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University Hospital, ToursInstitut Cancerologie de l'OuestTerminatedMetastatic Breast Cancer | Estrogen Receptor Positive Tumor | Progesterone Receptor Positive Tumor | HER-2 Negative TumorFrance
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Orum Therapeutics USA, Inc.RecruitingHER2-positive Breast Cancer | HER-2 Gene Amplification | HER2 Gene Mutation | HER-2 Protein OverexpressionUnited States
Clinical Trials on Etoposide
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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator...UnitedHealthcareActive, not recruitingSmall Cell Lung CancerUnited States
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University Hospital, BonnCompletedEpendymomas | Recurrent Brain Tumors | Supratentorial PNETs | MedulloblastomasGermany
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Sun Yat-sen UniversityRecruitingSmall Cell Lung CarcinomaChina
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Guizhou Medical UniversityUnknownSmall-cell Lung CancerChina
-
Third Military Medical UniversityUnknownExtensive-stage Small Cell Lung Cancer
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Jiangsu HengRui Medicine Co., Ltd.Enrolling by invitation
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CephalonWithdrawn
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Qingdao UniversityUnknownProgression Free SurvivalChina
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Annick DesjardinsAstraZenecaCompletedGlioblastoma | GliosarcomaUnited States
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Shanghai Henlius BiotechRecruitingExtensive Stage Small Cell Lung CancerUnited States