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Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT00810017
Recruitment Status : Terminated (Terminated due to difficulty in accruing patients)
First Posted : December 17, 2008
Last Update Posted : November 7, 2011
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Washington Hospital Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
HER-2 Positive Metastatic Breast Cancer Drug: Etoposide Drug: Trastuzumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study Combining Trastuzumab With Etoposide in Treatment of HER2-Positive Metastatic Breast Cancer.
Study Start Date : February 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: Etoposide
    etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles
    Other Names:
    • Eposin
    • Etopophos
    • Vepesid
    • VP-16
    Drug: Trastuzumab
    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 Name: Herceptin

Outcome Measures
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Primary Outcome Measures :
  1. 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: quarterly ]

Secondary Outcome Measures :
  1. To explore relationship of amplification or deletion of the TOP2A gene to efficacy of trastuzumab combined with etoposide in patients with HER2 positive metastatic breast cancer. [ Time Frame: yearly ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810017


Locations
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Washington Hospital Center
Genentech, Inc.
Investigators
Principal Investigator: Sandra M Swain, MD Washington Hospital Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Washington Hospital Center
ClinicalTrials.gov Identifier: NCT00810017     History of Changes
Other Study ID Numbers: IIT_H446Us
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: November 7, 2011
Last Verified: November 2011

Keywords provided by Washington Hospital Center:
Her2 Positive
Breast Cancer
Metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Etoposide phosphate
Trastuzumab
 Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action