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:
Washington Hospital Center
Collaborator:
Genentech
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HER-2 Positive Metastatic Breast Cancer |
Drug: Etoposide Drug: Trastuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Clinical Study Combining Trastuzumab With Etoposide in Treatment of HER2-Positive Metastatic Breast Cancer. |
Resource links provided by NLM:
Further study details as provided by Washington Hospital Center:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 2 |
| Study Start Date: | February 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Etoposide
- Eposin
- Etopophos
- Vepesid
- VP-16
etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles
Other Names:
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810017
Locations
| United States, District of Columbia | |
| Washington Cancer Institute | |
| Washington, District of Columbia, United States, 20010 | |
Sponsors and Collaborators
Washington Hospital Center
Genentech
Investigators
| Principal Investigator: | Sandra M Swain, MD | Washington Hospital Center |
More Information
No publications provided
| Responsible Party: | Washington Hospital Center |
| ClinicalTrials.gov Identifier: | NCT00810017 History of Changes |
| Other Study ID Numbers: | IIT_H446Us |
| Study First Received: | December 16, 2008 |
| Last Updated: | November 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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 |
Etoposide phosphate Trastuzumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013