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

NCT ID: NCT00810017

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-06-30

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.

Conditions

HER-2 Positive Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Etoposide

Intervention Type: DRUG

etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles

Trastuzumab

Intervention Type: DRUG

intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease

Interventions

Etoposide

etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Eposin; Etopophos; Vepesid; VP-16; Herceptin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra M Swain, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

IIT_H446Us

Identifier Type: -

Identifier Source: org_study_id