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Relapsed Breast CancerPhase 2NCT00479856

Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer

A Phase 2 study testing Lapatinib, Capecitabine and Docetaxel in people with Relapsed Breast Cancer and Neoplasms, Breast, run by GlaxoSmithKline at 28 sites in United States.

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 will evaluate the safety and efficacy of lapatinib in combination with chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing breast cancer whose disease has progressed during or within 12 months after completion of trastuzumab-containing therapy in the neoadjuvant or… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Relapsed Breast Cancer, Neoplasms, Breast
What is being tested?
Lapatinib, Capecitabine and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
28 sitesUnited States
Study dates
Nov 2007to Mar 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed informed consent.
  • Histologically/cytologically confirmed breast cancer;
  • If the disease is restricted to a solitary lesion, the neoplastic nature of the lesion must be confirmed by cytology or histology.
  • Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) [Therasse, 2000].
  • Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) or documented overexpression of the ErbB2 protein by 3+ IHC in primary or metastatic tumor tissue.
  • Subjects must have relapsed breast cancer where the disease progressed during or ≤ 12 months after completion of trastuzumab-containing therapy in the neoadjuvant or adjuvant setting.
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  • Note: Progression is defined using RECIST criteria, that is, either the appearance of new lesions or a >=20% increase in the sum of longest diameter (LD).
  • Subjects must not have received prior anti-cancer therapy for metastatic breast cancer (MBC). Subjects who received prior antihormonal agents combined with trastuzumab for the treatment of disease which first presented as ER positive MBC and recurred while receiving trastuzumab or ≤ 3 months after completing this therapy are eligible.
  • Subjects with stable central nervous system (CNS) metastases as confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) are allowed. Treatment with prophylactic anticonvulsants is permitted, unless listed within the Prohibited Medications.
  • Subjects must have a baseline cardiac ejection fraction (LVEF) ³50% measured by echocardiogram (ECHO) (or multigated acquisition (MUGA) scan if an ECHO cannot be performed). The same modality used at baseline must be used for repeat assessment throughout study. Only subjects with controlled or asymptomatic angina or arrhythmias are eligible.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2.
  • Subjects must have archived tumor tissue from the initial diagnosis available for analysis. If tissue from the initial diagnosis is not available, then tissue must be obtained from a recurrent or metastatic site prior to initiating study treatment.
  • Female ≥18 years.
  • Subject must have adequate organ function as defined in Table 1.
  • Table 1: Baseline Laboratory Values for Adequate Organ Function.
  • SYSTEM
  • Hematologic:
  • Absolute neutrophil count: ≥1.5 X 10^9/L
  • Hemoglobin: ≥9 g/dL
  • Platelets: ≥ 75 X 10^9/L
  • Hepatic:
  • AST, ALT and Alkaline phosphatase: ≤ 2.5 X ULN
  • Unless concomitant docetaxel, then ≤ 1.5 x ULN for AST and ALT, with AP ≤ 2.5 x ULN
  • Unless documented liver metastasis, then ≤ 5 x ULN
  • Serum bilirubin: ≤ 2.0 X ULN
  • Albumin: ≥ 2.5 g/dL
  • Renal:
  • Serum Creatinine: ≤ 1.5 mg/dL
  • OR - Calculate Creatinine Clearance: ≥ 40 mL/min
  • Calculated by the Cockcroft and Gault Method [Cockcroft , 1976].

Who cannot join

  • Pregnant or lactating females.
  • Women of childbearing potential who do not practice approved contraceptive methods (for example, intrauterine device [IUD], birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product.
  • History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • Concurrent therapy given to treat cancer (chemotherapy, radiation therapy, immunotherapy, biologic therapy, anti-hormonal therapy) while taking study medication.
  • Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
  • Malabsorption syndrome or resection of the stomach or small bowel significantly affecting gastrointestinal function.
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  • Have current active haptic or biliary disease (with excpetion of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
  • Concurrent disease or condition that, in the opinion of the physician, would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety (for example, uncontrolled infection, or any psychiatric condition prohibiting understanding or rendering of informed consent).
  • Concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents for anti-cancer therapy.
  • Bisphosphonates may not be initiated after the first dose of study medication.
  • Considered by the Investigator to have a life expectancy less than 3 months.
  • Not able to swallow or retain oral medication.
  • The subject with a known unmanageable hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients and those related to capecitabine, docetaxel, nab paclitaxel or their excipients.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • GSK Investigational Site

    Abingdon, Virginia, 24211

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131-0001

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Atlanta, Georgia, 30341

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Baltimore, Maryland, 21237

  • GSK Investigational Site

    Burbank, California, 91505

  • GSK Investigational Site

    Fairfax, Virginia, 22031

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33328

  • GSK Investigational Site

    Highland, California, 92346

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Hot Springs, Arkansas, 71913

  • GSK Investigational Site

    Indianapolis, Indiana, 46227

  • GSK Investigational Site

    Lawrenceville, Georgia, 30045

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Minneapolis, Minnesota, 55426

  • GSK Investigational Site

    New Orleans, Louisiana, 70112

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Ogden, Utah, 84403

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Sacramento, California, 95819

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Sumter, South Carolina, 29150

  • GSK Investigational Site

    Tupelo, Mississippi, 38801

  • GSK Investigational Site

    Voorhees Township, New Jersey, 08043

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Zion, Illinois, 60099

Other trials in United States

About this study

Official title: An Open-label, Multi-centre Study of Lapatinib in Combinationwith Chemotherapy in Patients With ErbB2 Overexpressing Breastcancer After Trastuzumab Failure in the Neoadjuvant or Adjuvantsetting.

This study will evaluate the safety and efficacy of lapatinib in combination with chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing breast cancer whose disease has progressed during or within 12 months after completion of trastuzumab-containing therapy in the neoadjuvant or adjuvant setting.

Being tested
Lapatinib, Capecitabine, Docetaxel, nab-Paclitaxel
Keywords
ErbB1, ErbB2, GW572016, lapatinib, Relapsed breast cancer, dual tyrosine kinase inhibitor, MBC, EGFR, Her-2/neu, FISH amplification
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT00479856
Study groupRoleWhat they receive
Lapatinib plus ChemotherapyExperimentalLapatinib is administered in combination with one of the following chemotherapies based on the discretion of the investigator : capecitabine, docetaxel or nab-paclitaxel.
Receives: Drug: Lapatinib; Drug: Capecitabine; Drug: Docetaxel; Drug: nab-Paclitaxel

What is being measured

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

  1. Overall Tumor Response

    Overall tumor response is defined as the percentage of participants with a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as the disappearance of all target lesions. CR could only be declared if all target and non-target lesions had disappeared. Partial response (PR) is defined as a decrease of 30% or greater in the sum of the longest diameter of target lesions.

    Measured: from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 wks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, of other reason)

Secondary outcomes (5)

  1. Clinical Benefit (CB)

    CB is defined as the percentage of participants (par.) with either a confirmed CR or PR or stable disease (SD) for at least 24 weeks. SD is defined as small changes that do not meet criteria for CR, PR, or Progressive Disease (defined as at least a 20% increase in the sum of the longest diameter of target lesions).

    Measured: from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)

  2. Duration of Response

    For the subset of participants with a confirmed CR or PR, duration of response was measured as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.

    Measured: time from first documented evidence of CR or PR until the first documented sign of disease progression or death (approximately 95 weeks)

  3. Time to Response (TTR)

    TTR is defined as the time from the start of treatment until the first documented evidence of PR or CR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the TTR was taken to be the first time that the response was observed.

    Measured: start of treatment until first documented evidence of CR or PR (approximately 95 weeks)

  4. Progression-free Survival

    The time from the start of treatment until the earliest date of disease progression or death due to any cause was measured.

    Measured: from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks); dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)

  5. Number of Participants With the Indicated Serious Adverse Events and Adverse Events

    Qualitative and quantitative toxicities associated with the combination of capecitabine, docetaxel, or nab-paclitaxel and lapatinib were measured. Data are presented as serious adverse events (SAEs) and adverse events (AEs). See the SAE/AE section of the results record for data.

    Measured: Baseline through End of Treatment, or discontinuation of study therapy (approximately 95 weeks); from the first dose of lapatinib until 5 days after the last dose of lapatinib

Timeline

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

  1. First posted28 May 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionSep 2009
  4. Study completionMar 2010

Why it stopped: Study was terminated due to difficulty in identifying eligible subjects

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00479856
Sponsor's protocol ID
EGF108916
Status last verified
Jun 2011
First submitted
25 May 2007
Last updated
5 Jun 2012

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lapatinib, Capecitabine and Docetaxel in people with Relapsed Breast Cancer and Neoplasms, Breast, run by GlaxoSmithKline at 28 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?

The sponsor lists 30 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 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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?

Yes. Results are posted in the registry (first posted 2 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Tumor Response (time frame: from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 wks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, of other reason)). 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 NCT00479856.

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 5 Jun 2012.

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