Status:
TERMINATED
Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Genentech, Inc.
Conditions:
HER-2 Positive Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (goo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00810017
Start Date
February 1 2009
End Date
June 1 2010
Last Update
May 19 2022
Active Locations (1)
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1
Washington Cancer Institute
Washington D.C., District of Columbia, United States, 20010