Breast CancerPhase 1NCT00544804
Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2
A Phase 1 study testing lapatinib ditosylate, gene expression analysis and diagnostic laboratory biomarker analysis in people with Breast Cancer and Metastatic Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Cancer
- What is being tested?
- lapatinib ditosylate, gene expression analysis and diagnostic laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2013
- Phase
- Phase 1
- 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
Who may be able to join
- ECOG performance status 0-2
- Life expectancy > 3 months
- Female
- Menopausal status not specified
- Absolute neutrophil count ≥ 1,000 cells/mm^3
- Hemoglobin ≥ 9 g/dL
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- Platelet count ≥ 75,000 cells/mm^3
- Total bilirubin normal
- AST and ALT ≤ 3 x upper limits of normal (ULN) (≤ 5 x ULN with liver metastases)
- Creatinine normal OR creatinine clearance ≥ 40 mL/min
- INR ≤ 1.5
- Potassium normal
- Magnesium normal
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception prior to and during study therapy
- Cardiac ejection fraction ≥ 50%
- Consents to 2 tumor fine needle aspiration biopsies for biomarker analysis
- Lung-only disease or sites otherwise deemed high-risk for biopsy, the requirement for biopsy will be waived
Who cannot join
- History of significant cardiac disease including any of the following:
- Congestive heart failure
- Symptomatic cardiac arrhythmias
- Unstable angina
- Uncontrolled prior lapatinib ditosylate therapy toxicity ≥ grade 2
- Allergic reactions to IV contrast dye despite standard prophylaxis
Show all 20Show fewer
- History of malabsorption syndrome or disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism, or excretion of study drug
- Conditions that would impair the patient's ability to swallow and retain oral medication
- Concurrent disease or condition that would make the patient inappropriate for study participation or would interfere with the patient's safety
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
- PRIOR CONCURRENT THERAPY:
- Prior lapatinib ditosylate or trastuzumab allowed
- At least 4 weeks since prior and no concurrent chemotherapy or investigational anticancer agents
- At least 2 weeks since prior and no concurrent hormonal therapy
- At least 2 weeks since prior and no concurrent lapatinib ditosylate prohibited medications, including CYP3A4 inhibitors or inducers, all herbal supplements, and gastric pH modifiers
- More than 4 weeks since prior radiotherapy
- No aspirin or plavix therapy within 7 days prior to tumor biopsy
- No concurrent coumadin
- Low molecular weight heparin allowed provided it can be held at least 24 hours prior to tumor biopsy
- Concurrent gonadal suppression agents (i.e., Zoladex or Lupron) or palliative bisphosphonates (i.e., Zometa) allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Phase I Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose (MTD) of high-dose lapatinib ditosylate in patients with HER2-overexpressing advanced or metastatic breast cancer.
- To determine the dose-limiting toxicity of this drug in these patients.
Secondary
- To determine whether tumor HER2 can be completely inactivated by lapatinib ditosylate at its MTD in the 5-day schedule.
- To determine whether the total inactivation of HER2 decreases cardiac ejection fraction.
OUTLINE: Patients are stratified according to dose level.
Patients receive escalating doses of oral lapatinib ditosylate twice daily on days 1-5 until the maximum tolerated dose is determined. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Some patients undergo tumor tissue and blood sample collection periodically for biological and correlative studies. Samples are analyzed for evidence of cardiac injury, tumor target lysis effects, and to determine if the lapatinib serum levels result in the inactivation of tumor HER2 and HER3 kinase and oncogenic signaling.
After completion of study treatment, patients are followed every 2 months.
- Conditions
- Breast Cancer, Metastatic Cancer
- Being tested
- lapatinib ditosylate, gene expression analysis, diagnostic laboratory biomarker analysis
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, bone metastases
- 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.
lapatinib ditosylateDrug
gene expression analysisGenetic
diagnostic laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Lapatinib | Experimental | Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer Receives: Drug: lapatinib ditosylate; Genetic: gene expression analysis; Other: diagnostic laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of Lapatinib
Dose Escalation of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
Measured: estimated to be 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2013
- Study completionDec 2013
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark M. Moasser, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544804
- Sponsor's protocol ID
- UCSF-077518
- Status last verified
- Jul 2014
- First submitted
- 13 Oct 2007
- Last updated
- 2 Jul 2014
- Results posted
- No
Publications
Chien AJ, Munster PN, Melisko ME, Rugo HS, Park JW, Goga A, Auerback G, Khanafshar E, Ordovas K, Koch KM, Moasser MM. Phase I dose-escalation study of 5-day intermittent oral lapatinib therapy in patients with human epidermal growth factor receptor 2-overexpressing breast cancer. J Clin Oncol. 2014 May 10;32(14):1472-9. doi: 10.1200/JCO.2013.52.1161. Epub 2014 Apr 7.
PubMed 24711549
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
- ClinicalTrials.gov ID
- NCT00544804
- Acronym / sponsor ID
- UCSF-077518
- Conditions
- Breast Cancer, Metastatic Cancer
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, bone metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Oct 2007 (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.
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose (MTD) of high-dose lapatinib ditosylate in patients with HER2-overexpressing advanced or metastatic breast cancer.
- To determine the dose-limiting toxicity of this drug in these patients.
Secondary
- To determine whether tumor HER2 can be completely inactivated by lapatinib ditosylate at its MTD in the 5-day schedule.
- To determine whether the total inactivation of HER2 decreases cardiac ejection fraction.
OUTLINE: Patients are stratified according to dose level.
Patients receive escalating doses of oral lapatinib ditosylate twice daily on days 1-5 until the maximum tolerated dose is determined. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Some patients undergo tumor tissue and blood sample collection periodically for biological and correlative studies. Samples are analyzed for evidence of cardiac injury, tumor target lysis effects, and to determine if the lapatinib serum levels result in the inactivation of tumor HER2 and HER3 kinase and oncogenic signaling.
After completion of study treatment, patients are followed every 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lapatinib | Experimental | Drug: lapatinib ditosylate, Genetic: gene expression analysis, Other: diagnostic laboratory biomarker analysisDose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- ECOG performance status 0-2
- Life expectancy > 3 months
- Female
- Menopausal status not specified
- Absolute neutrophil count ≥ 1,000 cells/mm^3
Key exclusion criteria (20 listed)
- History of significant cardiac disease including any of the following:
- Uncontrolled prior lapatinib ditosylate therapy toxicity ≥ grade 2
- Allergic reactions to IV contrast dye despite standard prophylaxis
- History of malabsorption syndrome or disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism, or excretion of study drug
- Conditions that would impair the patient's ability to swallow and retain oral medication
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 |
|---|---|---|
| lapatinib ditosylate | Drug | Lapatinib |
| gene expression analysis | Genetic | Lapatinib |
| diagnostic laboratory biomarker analysis | Other | Lapatinib |
Primary outcome
Maximum tolerated dose of Lapatinib
Time frame: estimated to be 12 months
Dose Escalation of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
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 2 Jul 2014.
- Results publication: PubMed 24711549Chien AJ, Munster PN, Melisko ME, Rugo HS, Park JW, Goga A, Auerback G, Khanafshar E, Ordovas K, Koch KM, Moasser MM. Phase I dose-escalation study of 5-day intermittent oral lapatinib therapy in patients with human epidermal growth factor receptor 2-overexpressing breast cancer. J Clin Oncol. 2014 May 10;32(14):1472-9. doi: 10.1200/JCO.2013.52.1161. Epub 2014 Apr 7.
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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.
Mark M. Moasser, MD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lapatinib ditosylate, gene expression analysis and diagnostic laboratory biomarker analysis in people with Breast Cancer and Metastatic Cancer, run by University of California, San Francisco 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 19 inclusion and 20 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: finished, as of the sponsor's last update on 2 Jul 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Maximum tolerated dose of Lapatinib (time frame: estimated to be 12 months). 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 NCT00544804, 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 2 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.