Metastatic Breast CancerPhase 2NCT00051103

Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

A Phase 2 study testing Investigational Cancer Drug in people with Metastatic Breast Cancer and Neoplasms, Breast, run by GlaxoSmithKline at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer, Neoplasms, Breast
What is being tested?: Investigational Cancer Drug
How many people: Not given
Where: 30 sitesUnited States
Study dates: Oct 2002to Jun 2005
Phase: Phase 2
Are there results?: None posted in the registry

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
Women only
No healthy volunteers
Adult, Older adult

Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)

Signed informed consent
No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.
Refractory Stage IIIb or IV breast cancer
HER2/neu tumor overexpression
Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.
Tumor tissue available for testing.
2 weeks since treatment with Herceptin (alone or in combination).
Able to swallow and retain oral medication
Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
Adequate kidney and liver function
Adequate bone marrow function

Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.)

Prior regimens did not include Herceptin.
Pregnant or lactating.
Conditions that would affect absorption of an oral drug
Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
Severe cardiovascular disease or cardiac disease requiring a device.
Active infection.
Brain metastases.
Concurrent cancer therapy or investigational therapy.
Use of oral or IV steroids.
Unresolved or unstable serious toxicity from prior therapy.
Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Bettendorf, Iowa, 52722
GSK Investigational Site
Billings, Montana, 59101
GSK Investigational Site
Chula Vista, California, 91911
GSK Investigational Site
Columbia, South Carolina, 29210
GSK Investigational Site
Des Moines, Iowa, 50309
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Fargo, North Dakota, 58103
GSK Investigational Site
Fort Myers, Florida, 33901
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Greenville, North Carolina, 27834
GSK Investigational Site
Hickory, North Carolina, 28602
GSK Investigational Site
Hooksett, New Hampshire, 03106
GSK Investigational Site
Houston, Texas, 77025
GSK Investigational Site
Los Angeles, California, 90095
GSK Investigational Site
Memphis, Tennessee, 38104
GSK Investigational Site
Memphis, Tennessee, 38120
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Nashville, Tennessee, 37205
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Park Ridge, Illinois, 60068
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Plantation, Florida, 33324
GSK Investigational Site
Poway, California, 92064
GSK Investigational Site
Royal Oak, Michigan, 48073
GSK Investigational Site
Salem, Virginia, 24153
GSK Investigational Site
Savannah, Georgia, 31405
GSK Investigational Site
Skokie, Illinois, 60076
GSK Investigational Site
Skokie, Illinois, 60077
GSK Investigational Site
Tulsa, Oklahoma, 74136

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

Conditions: Metastatic Breast Cancer, Neoplasms, Breast
Being tested: Investigational Cancer Drug
Keywords: Refractory
Medical subject headings: Breast Neoplasms

What participants receive

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

Investigational Cancer DrugDrug

Timeline

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

Oct 2002Jun 2005

First posted6 Jan 2003 (estimated)
Study startOct 2002
Primary completionJun 2005
Study completionJun 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00051103
Sponsor's protocol ID: EGF 20002
Status last verified: Apr 2015
First submitted: 3 Jan 2003
Last updated: 15 Apr 2015
Results posted: No

Publications

Blackwell KL, Pegram MD, Tan-Chiu E, Schwartzberg LS, Arbushites MC, Maltzman JD, Forster JK, Rubin SD, Stein SH, Burstein HJ. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol. 2009 Jun;20(6):1026-31. doi: 10.1093/annonc/mdn759. Epub 2009 Jan 29.
PubMed 19179558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

All Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens
ClinicalTrials.gov ID: NCT00051103
Acronym / sponsor ID: EGF 20002
Conditions: Metastatic Breast Cancer, Neoplasms, Breast
Keywords: Refractory
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2002
Primary completion: Jun 2005 (actual)
Study completion: Jun 2005 (actual)
First posted: 6 Jan 2003 (estimated)
Results: Not posted in the source record

Clinical summary

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

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

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

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
Investigational Cancer Drug	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
Background: PubMed 19179558Blackwell KL, Pegram MD, Tan-Chiu E, Schwartzberg LS, Arbushites MC, Maltzman JD, Forster JK, Rubin SD, Stein SH, Burstein HJ. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol. 2009 Jun;20(6):1026-31. doi: 10.1093/annonc/mdn759. Epub 2009 Jan 29.
A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.Link provided by the sponsor.

Related trials for Metastatic Breast Cancer

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

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.

GSK Clinical Trials study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigational Cancer Drug in people with Metastatic Breast Cancer and Neoplasms, Breast, run by GlaxoSmithKline at 30 sites 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?

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: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00051103, which also lists 1 linked publication.

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 15 Apr 2015.