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Breast NeoplasmsPhase 2NCT01557764

Lapatinib With Trastuzumab in Treating Patients With HER2-Negative/HER2 Mutant Metastatic Breast Cancer

A Phase 2 study testing lapatinib ditosylate and trastuzumab in people with Breast Neoplasms, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies the effectiveness of lapatinib ditosylate (lapatinib) together with trastuzumab in treating patients with HER2-negative breast cancer that carries HER2 gene mutations. Lapatinib may kill tumor cells by blocking some of the enzymes needed for cell division and growth. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
lapatinib ditosylate and trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2012to Mar 2016
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have histologically or cytologically confirmed metastatic breast cancer
  • The breast cancer has been tested negative for HER2 (0 or 1+ by immunohistochemistry [IHC] or non-amplified by fluorescence in-situ hybridization [FISH])
  • Patient may have measurable or evaluable disease
  • If given prior radiotherapy and/or prior chemotherapy, the patient must have completed radiation therapy and be at least 1 week from the last chemotherapy administration, with adequate recovery of bone marrow and organ functions, before starting lapatinib or trastuzumab
  • Note that the HER2 sequencing analysis can be performed while patient is receiving other systemic therapies so the results could be used to determine whether the patient is eligible to receive lapatinib and trastuzumab when disease progresses from current therapy
  • Patient must have had at least one lines of systemic therapy for metastatic breast cancer
Show all 17Show fewer
  • Patient must have disease that progressed on his/her most recent treatment regimen
  • Patient must be > 18 years of age.
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) unless due to Gilbert's syndrome
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3.0 x IULN with/without liver metastases
  • Creatinine =< 1.5 x IULN
  • Patient must have a left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (ILLN) to be eligible for study treatment; to avoid the cost of screening, patients with known recent LVEF < LLN or symptoms of congestive heart failure are not eligible for registration
  • Women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
  • Patient (or legally authorized representative if applicable) must be able to understand and willing to sign an institutional review board (IRB) approved written informed consent document
  • Patients with known treated brain metastasis are eligible, but must have received radiation and be off steroids and stable for 3 months
  • Patients meeting all inclusion criteria listed above and exclusion criteria will be registered to undergo HER2 mutation analysis; only patients with mutations in HER2 either in the primary or metastatic tumor are eligible for study therapy with lapatinib and trastuzumab; those without mutations in HER2 are not eligible for study drug therapy; information and tissue collected from patients without HER2 mutations will be used for molecular epidemiology studies of HER2 negative breast cancer

Who cannot join

  • Patient must not be receiving any other investigational agents
  • Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patient must not have acute or currently active/requiring antiviral therapy hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
  • Patient must not be pregnant and/or breastfeeding
  • Patient must not have a history of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias
  • Patient must not have symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest

About this study

Official title: A Phase II Study of Lapatinib in Combination With Trastuzumab in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

This phase II trial studies the effectiveness of lapatinib ditosylate (lapatinib) together with trastuzumab in treating patients with HER2-negative breast cancer that carries HER2 gene mutations. Lapatinib may kill tumor cells by blocking some of the enzymes needed for cell division and growth. Trastuzumab, a monoclonal antibody, may block the ability of tumor cells to grow and spread. Giving lapatinib together with trastuzumab may provide a more effective treatment for patients with this type of cancer.

Being tested
lapatinib ditosylate, trastuzumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • lapatinib ditosylateDrug

    Also called GSK572016, GW-572016, GW2016, Lapatinib, Tykerb

    Given PO

  • trastuzumabBiological

    Also called anti-c-erB-2, Herceptin, MOAB HER2, MOAB HER2, monoclonal antibody c-erb-2, monoclonal antibody HER2

    Given IV

Study groups in NCT01557764
Study groupRoleWhat they receive
Treatment (enzyme inhibitor and monoclonal antibody)ExperimentalPatients receive lapatinib PO QD on days 1-21 and trastuzumab IV over 90 minutes on day 1 of a 21-day cycle. Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Drug: lapatinib ditosylate; Biological: trastuzumab

What is being measured

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

  1. Overall clinical benefit rate (CBR; CD + PR + SD) of lapatinib and trastuzumab in patients with breast cancer that carry HER2 mutations

    Responses assessed using RECIST guidelines version 1.1; duration of SD must be >= 6 months; CBR and its 80% confidence interval will be calculated.

    Measured: 6 months

Secondary outcomes (6)

  1. PFS of patients treated with lapatinib and trastuzumab

    Assessed using RECIST guidelines version 1.1

    Measured: 2 years

  2. Correlation of HER2 mutation with histology subtype (invasive lobular vs. invasive ductal cancer)

    Measured: Baseline

  3. Correlation of HER2 mutation with tumor grade (1-2 vs. 3)

    Measured: Baseline

  4. Correlation of HER2 mutation with tumor staging at initial diagnosis (I vs. II or III vs. IV)

    Measured: Baseline

  5. Correlation of HER2 mutation with disease free survival

    Measured: 2 years

  6. Occurrence of HER2 mutation in paired primary and metastatic sites

    Measured: Baseline

Timeline

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

  1. First posted19 Mar 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMar 2016 (estimated)
  4. Study completionMar 2016 (estimated)

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01557764
Sponsor's protocol ID
201206025
Status last verified
Jul 2013
First submitted
15 Mar 2012
Last updated
4 Jul 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib ditosylate and trastuzumab in people with Breast Neoplasms, run by Washington University School of Medicine.

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 17 inclusion and 6 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: withdrawn, as of the sponsor's last update on 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Overall clinical benefit rate (CBR; CD + PR + SD) of lapatinib and trastuzumab in patients with breast cancer that carry HER2 mutations (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 NCT01557764.

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 4 Jul 2013.

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