DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Washington Hospital Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HER-2 Positive Metastatic Breast Cancer

Intervention: Etoposide (Drug); Trastuzumab (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Washington Hospital Center

Official(s) and/or principal investigator(s):
Sandra M Swain, MD, Principal Investigator, Affiliation: Washington Hospital Center

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.

Clinical Details

Official title: Phase II Clinical Study Combining Trastuzumab With Etoposide in Treatment of HER2-Positive Metastatic Breast Cancer.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Washington Cancer Institute, Washington, District of Columbia 20010, United States
Additional Information

Starting date: February 2009
Last updated: November 4, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017