Her2 Positive Metastatic Breast CancerPhase 1/2NCT01495884

The Myocet/Lapatinib Study. ICORG 10-03, V5

A Phase 1/2 study testing non-pegylated liposomal doxorubicon (Myocet™) and Lapatinib (Tyverb™) in people with Her2 Positive Metastatic Breast Cancer, run by Cancer Trials Ireland at 10 sites in Ireland.

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 a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic breast cancer, following disease progression during, or after, treatment with trastuzumab and taxanes, will be treated with Lapatinib (Tyverb™ 500-1250 mg orally daily - depending on the maximum tolerated dose (MTD) determined… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Her2 Positive Metastatic Breast Cancer
What is being tested?: non-pegylated liposomal doxorubicon (Myocet™) and Lapatinib (Tyverb™)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 10 sitesIreland
Study dates: Mar 2011to Oct 2014
Phase: Phase 1/2
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

Who may be able to join

Written informed consent obtained prior to any study-related procedures.
Female patients, age ≥ 18 years, who are either post menopausal (post-menopausal status will be defined as patients who are amenorrheic for > 1 year or for a shorter duration if FSH, LH and/or oestradiol levels are within the post-menopausal range), surgically sterile or practicing an effective method of birth control agreed with the patients study physician. Women of childbearing potential should use an effective contraceptive ( such as non hormonal intra uterine device (IUD), condoms, sexual abstinence or vasectomised partner).during treatment and up to 6 months following discontinuation of therapy.
Histologically confirmed metastatic breast cancer
Documented HER2 overexpression (IHC 3+ or FISH or CISH positive)
At least one measurable lesion according to RECIST criteria. Patients with bone only disease are not eligible.
Patients with controlled brain metastasis are eligible.

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Documented disease progression. Progression for entry is defined as appearance of any new lesion not previously identified or increase of 25% or more in existent lesion from previous CT scan and must be documented
Prior treatment must have contained trastuzumab and taxane. Patients may have been treated with Lapatinib previously.
Life expectancy of at least 12 weeks
ECOG Performance Status of ≤ 2
Left ventricular ejection fraction (LVEF) ≥ 55%, as measured by Echocardiogram or MUGA Scan (within 14 days prior to first infusion), and no documented history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure within the previous 6 months
Adequate bone marrow, haematological, hepatic and renal function defined as:
Absolute Neutrophils Count ≥ 1.5 x 109/L
Platelet Count ≥ 100 x 109/L
Haemoglobin ≥ 9.0 g/dL
Calculated creatinine clearance ≥ 40 mL/min
Total bilirubin ≤ ULN. Patients with Gilbert's syndrome prior to study entry must have total bilirubin < 3 x ULN.
Alkaline Phosphatase and AST or ALT within the parameters specified in protocol
Patients must have recovered from clinically significant side effects associated with prior radiotherapy and chemotherapy
Able to swallow and retain oral medication.
Formalin-fixed paraffin-embedded tissue from archived tumour tissue samples available (from the primary or metastatic tissue.
Patients meeting any of the following exclusion criteria are not eligible for enrolment into this study:

Who cannot join

Pregnant or lactating women
Prior anthracycline chemotherapy with a lifetime dose exceeding 360 mg/m2 doxorubicin or 550 mg/m2 epirubicin
Documented history of poorly controlled hypertension), arrhythmia, clinically significant valvular disease, angina requiring treatment, transmural infarction, myocardial infarction within the previous 6 months
Concurrent disease that would make the patient inappropriate for study participation, or any other serious medical disorder that would interfere with the patient's safety
Dementia, altered mental status, or any other psychiatric condition that would interfere with the patient's safety or informed consent
Active or uncontrolled bacterial, viral or fungal infection.

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History of other malignancy. However patients who have been disease free for 5 years, or patients with a history of resected non-melanoma skin cancer or successfully treated in situ cancer are eligible
Concurrent cancer therapy (chemotherapy, immunotherapy, biologic therapy, hormonal therapy, or within 4 weeks preceding the first dose of investigational product)
Unresolved or unstable, serious toxicity from prior administration of another investigational product
Concurrent treatment with an investigational drug within 4 weeks preceding the first dose of investigational product
Known hypersensitivity to lapatinib and Myocet™ or their excipients
Any other contraindications for lapatinib and Myocet™
Receive concurrent treatment with prohibited medications. Zometa for patients with bone metastasis is allowed. If the patient is on Zometa at start of the study, it should be continued throughout the duration of the study.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Ireland10 sites

Bon Secours Hospital
Cork
Cork University Hospital
Cork
Beaumont Hospital
Dublin
Mater Misercordiae University Hospital
Dublin
Mater Private Hospital
Dublin
St James's Hospital
Dublin
St. Vincent's University Hospital
Dublin
University Hospital Galway
Galway
University Hospital Limerick
Limerick
Waterford Regional Hospital
Waterford

Other trials in Ireland

About this study

Official title: A Phase I/II Study of Lapatinib Plus Myocet TM in Patients With HER2+ve Metastatic Breast Cancer Following Disease Progression During, or After, Treatment With Trastuzumab and Taxanes

Within the Phase I part, doses are assigned at registration according to the dose escalation scheme.

The dose for the Phase II part of the trial will be based on the MTD established in the Phase I part of the study.

Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity of study therapy. Safety assessments will be performed every 3 weeks for the first 24 weeks. Efficacy assessments (radiological examination) will be performed on all patients every 8 weeks (± 7 days) for the first 24 weeks. Cardiotoxicity assessments will be performed at weeks 6 and 12. From week 24, safety, efficacy and cardiotoxicity assessments will be performed every 12 weeks and at the end of treatment (disease progression, unacceptable toxicity or patient withdraws consent).

Read the detailed description

Primary Objective:

To determine the optimal dose for lapatinib plus Myocet™, in combination, in patients with HER2-positive metastatic breast cancer following disease progression during, or after, treatment with trastuzumab and taxanes (Phase I).
To evaluate the 6 month progression-free survival of patients with HER2-positive metastatic breast cancer, following disease progression during, or after, treatment with trastuzumab and taxanes, who are treated with lapatinib plus Myocet™ (Phase II plus patients treated at MTD in Phase I).

Secondary Objectives:

To evaluate the overall survival time, duration of progression -free survival, time to treatment failure, confirmed tumour response rate and duration of response in patients treated with this regimen (Phase II plus patients treated at MTD in Phase I).
To assess the safety and tolerability of this regimen in these patients.
To assess the incidence of cardiotoxicity in these patients treated with this regimen.

Conditions: Her2 Positive Metastatic Breast Cancer
Being tested: non-pegylated liposomal doxorubicon (Myocet™), Lapatinib (Tyverb™)

What participants receive

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

non-pegylated liposomal doxorubicon (Myocet™)Drug
Lapatinib (Tyverb™)Drug

Study groups in NCT01495884
Study group	Role	What they receive
Lapatinib (Tyverb™) and (Myocet™)	Experimental	Not described Receives: Drug: non-pegylated liposomal doxorubicon (Myocet™); Drug: Lapatinib (Tyverb™)

What is being measured

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

Optimal dose for lapatinib plus myocet
Determination of the optimal dose for lapatinib plus Myocet™, in combination, in patients with HER2-positive metastatic breast cancer following disease progression during, or after, treatment with trastuzumab and taxanes as measured by MTD (Phase I)
Measured: 6 months

Secondary outcomes (1)

Overall survival
overall survival time (OS - time from registration to death from any cause) as assessed by standard RECIST criteria
Measured: From registration to death

Timeline

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

Mar 2011Oct 2014

First posted20 Dec 2011 (estimated)
Study startMar 2011
Primary completionOct 2014
Study completionOct 2014

Why it stopped: Slower than anticipated accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Her2 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01495884
Sponsor's protocol ID: ICORG 10-03
Status last verified: Oct 2015
First submitted: 16 Dec 2011
Last updated: 26 Oct 2015
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Lapatinib Plus Myocet TM in Patients With HER2+ve Metastatic Breast Cancer Following Disease Progression During, or After, Treatment With Trastuzumab and Taxanes
ClinicalTrials.gov ID: NCT01495884
Acronym / sponsor ID: ICORG 10-03
Conditions: Her2 Positive Metastatic Breast Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slower than anticipated accrual
Enrolment: 11 participants (actual)
Lead sponsor: Cancer Trials IrelandResearch network
Study start: Mar 2011
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 20 Dec 2011 (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.

Within the Phase I part, doses are assigned at registration according to the dose escalation scheme.

The dose for the Phase II part of the trial will be based on the MTD established in the Phase I part of the study.

Detailed description

Primary Objective:

To determine the optimal dose for lapatinib plus Myocet™, in combination, in patients with HER2-positive metastatic breast cancer following disease progression during, or after, treatment with trastuzumab and taxanes (Phase I).
To evaluate the 6 month progression-free survival of patients with HER2-positive metastatic breast cancer, following disease progression during, or after, treatment with trastuzumab and taxanes, who are treated with lapatinib plus Myocet™ (Phase II plus patients treated at MTD in Phase I).

Secondary Objectives:

To evaluate the overall survival time, duration of progression -free survival, time to treatment failure, confirmed tumour response rate and duration of response in patients treated with this regimen (Phase II plus patients treated at MTD in Phase I).
To assess the safety and tolerability of this regimen in these patients.
To assess the incidence of cardiotoxicity in these patients treated with this regimen.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lapatinib (Tyverb™) and (Myocet™)	Experimental	Drug: non-pegylated liposomal doxorubicon (Myocet™), Drug: Lapatinib (Tyverb™)

Who may qualify

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

Key inclusion criteria (22 listed)

Written informed consent obtained prior to any study-related procedures.
Female patients, age ≥ 18 years, who are either post menopausal (post-menopausal status will be defined as patients who are amenorrheic for > 1 year or for a shorter duration if FSH, LH and/or oestradiol levels are within the post-menopausal range), surgically sterile or practicing an effective method of birth control agreed with the patients study physician. Women of childbearing potential should use an effective contraceptive ( such as non hormonal intra uterine device (IUD), condoms, sexual abstinence or vasectomised partner).during treatment and up to 6 months following discontinuation of therapy.
Histologically confirmed metastatic breast cancer
Documented HER2 overexpression (IHC 3+ or FISH or CISH positive)
At least one measurable lesion according to RECIST criteria. Patients with bone only disease are not eligible.

Key exclusion criteria (13 listed)

Pregnant or lactating women
Prior anthracycline chemotherapy with a lifetime dose exceeding 360 mg/m2 doxorubicin or 550 mg/m2 epirubicin
Documented history of poorly controlled hypertension), arrhythmia, clinically significant valvular disease, angina requiring treatment, transmural infarction, myocardial infarction within the previous 6 months
Concurrent disease that would make the patient inappropriate for study participation, or any other serious medical disorder that would interfere with the patient's safety
Dementia, altered mental status, or any other psychiatric condition that would interfere with the patient's safety or informed consent

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
non-pegylated liposomal doxorubicon (Myocet™)	Drug	Lapatinib (Tyverb™) and (Myocet™)
Lapatinib (Tyverb™)	Drug	Lapatinib (Tyverb™) and (Myocet™)

Primary outcome

Optimal dose for lapatinib plus myocet
Time frame: 6 months
Determination of the optimal dose for lapatinib plus Myocet™, in combination, in patients with HER2-positive metastatic breast cancer following disease progression during, or after, treatment with trastuzumab and taxanes as measured by MTD (Phase I)

1 secondary outcome

Overall survival
Time frame: From registration to death

Results and safety

The study was stopped early (reason given: Slower than anticipated accrual). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 22 inclusion and 13 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 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Ireland. 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 combined 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.

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 was stopped early (reason given: Slower than anticipated accrual). Results are not available in the source record.

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?

Optimal dose for lapatinib plus myocet (time frame: 6 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 NCT01495884.

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 26 Oct 2015.