Breast CancerPhase 1LAPATAMNCT00424164
Lapatinib and Tamoxifen in Treating Patients With Advanced or Metastatic Breast Cancer
A Phase 1 study testing lapatinib ditosylate, tamoxifen citrate and pharmacological study in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in France.
Trial summary
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- lapatinib ditosylate, tamoxifen citrate and pharmacological study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2006to 28 May 2010
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced or metastatic breast cancer
- Progressive disease after aromatase inhibitor therapy
- Hormone receptor status:
- Estrogen receptor- and/or progesterone receptor-positive tumor
- Patients with stable brain metastases (i.e., no neurological symptoms and no corticosteroid treatment) are eligible
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- AST and/or ALT < 3 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- Bilirubin < 1.5 times ULN
- Clinically normal cardiac function (i.e., LVEF normal by MUGA or ECHO)
- No current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic live disease)
- No ischemic heart disease within the past 6 months
- Normal 12-lead ECG
- No active or uncontrolled infections
- No serious illnesses or medical conditions, including any of the following:
- Hypercalcemia
- Malabsorption syndrome
- Chronic alcohol abuse
- Hepatitis
- HIV
- Cirrhosis
- Able to swallow and retain oral medication
- No psychological, familial, sociological, or geographical condition potentially hampering study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 days since prior and no concurrent inducers or inhibitors of CYP3A4, including any of the following:
- Rifabutin
- Clarithromycin
- Cyclosporine
- Voriconazole
- Fluoxetine
- Paroxetine
- Midazolam
- Isoniazid
- Dihydralazine
- Digitoxin
- Coumadin
- Phenytoin
- Verapamil
- Diltiazem
- Herbal constituents (e.g., bergamottin and glabridin)
- At least 2 weeks since prior aromatase inhibitor
- Aromatase inhibitors in the adjuvant and/or metastatic setting allowed
- At least 1 year since prior tamoxifen citrate
- No other concurrent anticancer therapy or investigational agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics Study of Combined Treatment Lapatinib and Tamoxifen in Advanced/Metastatic Breast Cancer
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer.
PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and tamoxifen in treating patients with advanced or metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the pharmacokinetics of lapatinib ditosylate and tamoxifen citrate in patients with advanced or metastatic breast cancer.
Secondary
- Assess the safety of this regimen in these patients.
- Determine any relationship between drug exposure and adverse events or biological modifications of this regimen in these patients.
- Assess the antitumor activity of this regimen in patients with measurable disease.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tamoxifen citrate on days 1-28 of course 1. In all subsequent courses, patients receive oral tamoxifen citrate and oral lapatinib ditosylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral lapatinib ditosylate on days 1-14 of course 1. In all subsequent courses, patients receive oral lapatinib ditosylate and oral tamoxifen citrate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
In both treatment arms, blood is collected periodically during courses 1 and 2 for pharmacokinetic studies.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- lapatinib ditosylate, tamoxifen citrate, pharmacological study
- Keywords
- male breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinib ditosylateDrug
tamoxifen citrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen-lapatinib | Experimental | Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib. Receives: Drug: lapatinib ditosylate; Drug: tamoxifen citrate; Other: pharmacological study |
| Lapatinib-tamoxifen | Experimental | Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen Receives: Drug: lapatinib ditosylate; Drug: tamoxifen citrate; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination
Measured: maximum 24h after the dose administered on Day 28
Secondary outcomes (3)
Safety
Measured: until disease progression or until the start of another treatment (average 2 months)
Relationship between drug exposure and adverse events or biological modifications
Measured: until disease progression or until the start of another treatment (average 2 months)
Response in patients with measurable disease
Measured: until disease progression or until the start of another treatment (average 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionJun 2009
- Study completion28 May 2010
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 European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Fumoleau, MD, PhD, Study chair, Centre Georges Francois Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424164
- Sponsor's protocol ID
- EORTC-10053
- Other IDs
- 2005-005196-14, 2005
- Acronym
- LAPATAM
- Status last verified
- Mar 2024
- First submitted
- 16 Jan 2007
- Last updated
- 8 Mar 2024
- Results posted
- No
Publications
Fumoleau P, Koch KM, Brain E, Lokiec F, Rezai K, Awada A, Hayward L, Werutsky G, Bogaerts J, Marreaud S, Cardoso F. A phase I pharmacokinetics study of lapatinib and tamoxifen in metastatic breast cancer (EORTC 10053 Lapatam study). Breast. 2014 Oct;23(5):663-9. doi: 10.1016/j.breast.2014.07.003. Epub 2014 Jul 24.
PubMed 25065668
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Combined Treatment Lapatinib and Tamoxifen in Advanced/Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00424164
- Acronym / sponsor ID
- LAPATAM / EORTC-10053
- Conditions
- Breast Cancer
- Keywords
- male breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Nov 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- 28 May 2010 (actual)
- First posted
- 18 Jan 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. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer.
PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and tamoxifen in treating patients with advanced or metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the pharmacokinetics of lapatinib ditosylate and tamoxifen citrate in patients with advanced or metastatic breast cancer.
Secondary
- Assess the safety of this regimen in these patients.
- Determine any relationship between drug exposure and adverse events or biological modifications of this regimen in these patients.
- Assess the antitumor activity of this regimen in patients with measurable disease.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tamoxifen citrate on days 1-28 of course 1. In all subsequent courses, patients receive oral tamoxifen citrate and oral lapatinib ditosylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral lapatinib ditosylate on days 1-14 of course 1. In all subsequent courses, patients receive oral lapatinib ditosylate and oral tamoxifen citrate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
In both treatment arms, blood is collected periodically during courses 1 and 2 for pharmacokinetic studies.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen-lapatinib | Experimental | Drug: lapatinib ditosylate, Drug: tamoxifen citrate, Other: pharmacological studyTamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib. |
| Lapatinib-tamoxifen | Experimental | Drug: lapatinib ditosylate, Drug: tamoxifen citrate, Other: pharmacological studyLapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- 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 |
|---|---|---|
| lapatinib ditosylate | Drug | Lapatinib-tamoxifen, Tamoxifen-lapatinib |
| tamoxifen citrate | Drug | Lapatinib-tamoxifen, Tamoxifen-lapatinib |
| pharmacological study | Other | Lapatinib-tamoxifen, Tamoxifen-lapatinib |
Primary outcome
Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination
Time frame: maximum 24h after the dose administered on Day 28
3 secondary outcomes
Safety
Time frame: until disease progression or until the start of another treatment (average 2 months)
Relationship between drug exposure and adverse events or biological modifications
Time frame: until disease progression or until the start of another treatment (average 2 months)
Response in patients with measurable disease
Time frame: until disease progression or until the start of another treatment (average 2 months)
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 8 Mar 2024.
- Derived from this study: PubMed 25065668Fumoleau P, Koch KM, Brain E, Lokiec F, Rezai K, Awada A, Hayward L, Werutsky G, Bogaerts J, Marreaud S, Cardoso F. A phase I pharmacokinetics study of lapatinib and tamoxifen in metastatic breast cancer (EORTC 10053 Lapatam study). Breast. 2014 Oct;23(5):663-9. doi: 10.1016/j.breast.2014.07.003. Epub 2014 Jul 24.
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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.
Pierre Fumoleau, MD, PhD study chair
Centre Georges Francois Leclerc
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, tamoxifen citrate and pharmacological study in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in France.
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 8 Mar 2024. 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 France. 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?
Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination (time frame: maximum 24h after the dose administered on Day 28). 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 NCT00424164, 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 8 Mar 2024.