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

Primary Purpose

HER-2 Positive Metastatic Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Etoposide

Trastuzumab

About this trial

This is an interventional treatment trial for HER-2 Positive Metastatic Breast Cancer focused on measuring Her2 Positive, Breast Cancer, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Washington Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression

Outcomes

Primary Outcome Measures

To Determine ORR 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.

To determine the overall response rate

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.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Determine Duration of Response

Stable disease

Determine Duration of Response

Time to disease progression

Determine Duration of Response

The duration of overall response will be measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started. The duration of overall CR is measured from the time measurements are met for CR until the first date that recurrent disease is objectively documented

Full Information

NCT ID

NCT00810017

First Posted

December 16, 2008

Last Updated

April 27, 2022

Sponsor

Medstar Health Research Institute

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00810017

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

Terminated due to difficulty in accruing patients

Study Start Date

February 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medstar Health Research Institute

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HER-2 Positive Metastatic Breast Cancer

Keywords

Her2 Positive, Breast Cancer, Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm study

Arm Type

Experimental

Arm Description

Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

Eposin, Etopophos, Vepesid, VP-16

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Herceptin

Intervention Description

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

Primary Outcome Measure Information:

Title

To Determine ORR 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.

Description

To determine the overall response rate

Time Frame

The best overall response is the best response recorded from the start of first treatment until the date of first progression or date of death from any cause whichever came first, assessed up to 24 months

Title

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

From the start of first treatment until unacceptable toxicity or date of death, whichever came first, over 24 months

Secondary Outcome Measure Information:

Title

Determine Duration of Response

Description

Stable disease

Time Frame

Stable disease is measured from the start of the treatment until the criteria for progression are met, assessed by CT scans at a minimum interval of 8 weeks over 5 years

Title

Determine Duration of Response

Description

Time to disease progression

Time Frame

Time to disease progression is defined as time from registration date to the date of documented disease progression or death on study, whichever occurs first for 5 years

Title

Determine Duration of Response

Description

Time Frame

The progression-free survival rate is defined as the percentage of patients who are without disease progression while on the study treatment at the end of study, over 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra M Swain, MD

Organizational Affiliation

Medstar Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington Cancer Institute

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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