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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00810017
Recruitment Status : Terminated (Terminated due to difficulty in accruing patients)
First Posted : December 17, 2008
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Medstar Health Research Institute

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: N/A
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

Arms and Interventions
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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
 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 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 ]
    To determine the overall response rate

  2. 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 ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. 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 ]
    Stable disease

  2. 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 ]
    Time to disease progression

  3. 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 ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
Genentech, Inc.
Investigators
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Principal Investigator: Sandra M Swain, MD Medstar Health Research Institute
More Information
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT00810017    
Other Study ID Numbers: IIT_H446Us
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medstar Health Research Institute:
Her2 Positive
Breast Cancer
Metastatic
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Etoposide
Trastuzumab
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological