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

This study has been terminated.
(Terminated due to difficulty in accruing patients)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Washington Hospital Center
ClinicalTrials.gov Identifier:
NCT00810017
First received: December 16, 2008
Last updated: November 4, 2011
Last verified: November 2011

December 16, 2008
November 4, 2011
February 2009
May 2010   (final data collection date for primary outcome 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. [ Time Frame: quarterly ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00810017 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HER-2 Positive Metastatic Breast Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
June 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810017
IIT_H446Us
Yes
Washington Hospital Center
Washington Hospital Center
Genentech, Inc.
Principal Investigator: Sandra M Swain, MD Washington Hospital Center
Washington Hospital Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP