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Neoplasms, BreastPhase 2NCT00089999

Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

A Phase 2 study testing Lapatinib in people with Neoplasms, Breast, run by GlaxoSmithKline at 31 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Breast
What is being tested?
Lapatinib
How many people
138 participants
Where
31 sitesin 11 countries
Study dates
Jun 2004to Mar 2008
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

  • Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
  • Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
  • Adequate renal, hepatic and cardiac function

Who cannot join

  • Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
  • Patients with active brain metastases
  • Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.

Trial locations and contacts

31 sites in 11 countries.

31 sites in 11 countries

Pakistan5 sites

  • GSK Investigational Site

    Karachi, 54000

  • GSK Investigational Site

    Karachi, 74800

  • GSK Investigational Site

    Karachi

  • GSK Investigational Site

    Lahore

  • GSK Investigational Site

    Rawalpindi

Other trials in Pakistan

Malaysia4 sites

  • GSK Investigational Site

    Bandar Tun Razak, Cheras, 59100

  • GSK Investigational Site

    Kubang Kerian, 16150

  • GSK Investigational Site

    Tanjong Bungah, 10450

  • GSK Investigational Site

    Tanjong Bungah, 11200

Other trials in Malaysia

Peru4 sites

  • GSK Investigational Site

    Callao, Callao 2

  • GSK Investigational Site

    Lima, Lima Province, Lima 11

  • GSK Investigational Site

    Lima, Lima Province, Lima 13

  • GSK Investigational Site

    Lima, Lima Province, Lima 34

Other trials in Peru

Chile3 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500921

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8380456

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

Other trials in Chile

India3 sites

  • GSK Investigational Site

    Delhi, 110085

  • GSK Investigational Site

    Hyderabad, Andhra Pradesh, 500482

  • GSK Investigational Site

    Pune, 411001

Other trials in India

Mexico3 sites

  • GSK Investigational Site

    Ixtaltepec / Espinal, Oaxaca, 70140

  • GSK Investigational Site

    Mérida, Yucatán, 97500

  • GSK Investigational Site

    México

Other trials in Mexico

Poland3 sites

  • GSK Investigational Site

    Bydogoszcz, 85-796

  • GSK Investigational Site

    Krakow, 31-115

  • GSK Investigational Site

    Olsztyn, 10-228

Other trials in Poland

Singapore2 sites

  • GSK Investigational Site

    Singapore, 169610

  • GSK Investigational Site

    Singapore, 258500

Other trials in Singapore

Taiwan2 sites

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 114

Other trials in Taiwan

United States1 site

  • GSK Investigational Site

    Hollywood, Florida, 33021

Other trials in United States

Hong Kong1 site

  • GSK Investigational Site

    Pokfulam

Other trials in Hong Kong

About this study

Official title: A Phase II, Open-Label, Randomized, Parallel-Group Multicenter Trial Comparing Two Schedules of GW572016 as First-Line Monotherapy in Patients With Advanced or Metastatic Breast Cancer

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

Being tested
Lapatinib
Keywords
lapatinib, advanced, metastatic breast cancer, GW572016, ErbB2
Medical subject headings
Breast Neoplasms

What participants receive

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

  • LapatinibDrug

What is being measured

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

  1. Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)

    OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.

    Measured: From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)

  2. Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator

    OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.

    Measured: From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)

Secondary outcomes (6)

  1. Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator

    Clinical benefit is defined as the numer of participants achieving either a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD,or complete resolution of TLs and the persistence of one or more non-TLs)or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new TLs or non-TLs and/or unequivocal progressionn of existing non-target lesions], taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.

    Measured: From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer (up to Study Week 103)

  2. Time to Response, as Assessed by the IRC and Investigator

    Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.

    Measured: From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 103)

  3. Duration of Response (DoR), as Assessed by the IRC and Investigator

    DoR is defined for the subset of par. who had a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of >= 1 non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. For par. who did not progress or die, DoR was censored on the date of the last radiological scan. If a par.had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.

    Measured: From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 103)

  4. Progression-free Survival, as Assessed by the IRC and Investigator

    Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the IRC's and investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who did not progress, or die, progression-free survival was censored at the time of the last IRC assessed radiological scan.

    Measured: From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 103)

  5. Time to Treatment Failure, as Assessed by IRC and Investigator

    Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death due any cause. For participants who did not progress, die or discontinue early, time to treatment failure was censored at the last scan date.

    Measured: From randomization until the first documented sign of disease progression, death due to any cause, or early discontinuation from investigational product (up to Study Week 103)

  6. Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.

    Measured: From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to study week 192)

Timeline

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

  1. First posted23 Aug 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionMar 2008
  4. Study completionMar 2008

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089999
Sponsor's protocol ID
EGF20009
Status last verified
Jan 2017
First submitted
18 Aug 2004
Last updated
28 Feb 2017
Data monitoring committee
No

Publications

  • Lipton A, Leitzel K, Ali SM, Carney W, Platek G, Steplewski K, Westlund R, Gagnon R, Martin AM, Maltzman J. Human epidermal growth factor receptor 2 (HER2) extracellular domain levels are associated with progression-free survival in patients with HER2-positive metastatic breast cancer receiving lapatinib monotherapy. Cancer. 2011 Nov 1;117(21):5013-20. doi: 10.1002/cncr.26101. Epub 2011 Mar 31.

    PubMed 21456017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lapatinib in people with Neoplasms, Breast, run by GlaxoSmithKline at 31 sites in 11 countries.

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 5 inclusion and 3 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Pakistan, Malaysia, Peru, Chile, India and 6 more countries. 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 29 Aug 2014). 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?

Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC) (time frame: From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)). The study lists 2 primary outcomes in all. 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 NCT00089999, 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 28 Feb 2017.

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