HER-2 Positive Metastatic Breast CancerPhase 2NCT00810017

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

A Phase 2 study testing Etoposide and Trastuzumab in people with HER-2 Positive Metastatic Breast Cancer, run by Medstar Health Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HER-2 Positive Metastatic Breast Cancer
What is being tested?: Etoposide and Trastuzumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Feb 2009to Jun 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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.

Who cannot join

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).

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington Cancer Institute
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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

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
Being tested: Etoposide, Trastuzumab
Keywords: Her2 Positive, Breast Cancer, Metastatic
Medical subject headings: Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EtoposideDrug
Also called Eposin, Etopophos, Vepesid, VP-16
etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles
TrastuzumabDrug
Also called Herceptin
intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease

Study groups in NCT00810017
Study group	Role	What they receive
Single arm study	Experimental	Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression Receives: Drug: Etoposide; Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Determine Duration of Response
Stable disease
Measured: 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
Determine Duration of Response
Time to disease progression
Measured: 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
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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Jun 2010

First posted17 Dec 2008 (estimated)
Study startFeb 2009
Primary completionMay 2010
Study completionJun 2010

Why it stopped: Terminated due to difficulty in accruing patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HER-2 Positive Metastatic Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00810017
Sponsor's protocol ID: IIT_H446Us
Status last verified: Apr 2022
First submitted: 16 Dec 2008
Last updated: 19 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Clinical Study Combining Trastuzumab With Etoposide in Treatment of HER2-Positive Metastatic Breast Cancer.
ClinicalTrials.gov ID: NCT00810017
Acronym / sponsor ID: IIT_H446Us
Conditions: HER-2 Positive Metastatic Breast Cancer
Keywords: Her2 Positive, Breast Cancer, Metastatic
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to difficulty in accruing patients
Enrolment: 2 participants (actual)
Lead sponsor: Medstar Health Research InstituteUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: Feb 2009
Primary completion: May 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 17 Dec 2008 (estimated)
Results: Posted 19 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single arm study	Experimental	Drug: Etoposide, Drug: TrastuzumabEtoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (11 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EtoposideAlso: Eposin, Etopophos, Vepesid, VP-16etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles	Drug	Single arm study
TrastuzumabAlso: Herceptinintravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease	Drug	Single arm study

Primary outcome

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.
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
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.
Time frame: From the start of first treatment until unacceptable toxicity or date of death, whichever came first, over 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

3 secondary outcomes

Determine Duration of Response
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
Determine Duration of Response
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
Determine Duration of Response
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

Results and safety

Results posted to the registry on 19 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm Study	2	0

Primary outcome: 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.

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

Population analysed: Study was terminated and no results were collected.

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.

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

Population analysed: Study was terminated and no results were collected.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study was terminated and no results were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm Study	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra M Swain, MD principal investigator

Medstar Health Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etoposide and Trastuzumab in people with HER-2 Positive Metastatic Breast Cancer, run by Medstar Health Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00810017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.