Neoplasms, BreastPhase 2NCT00320411
GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer
A Phase 2 study testing lapatinib in people with Neoplasms, Breast, run by GlaxoSmithKline at 9 sites in 2 countries.
Trial summary
This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. Read more about this study
- Who is it for?
- Ages 20 to 74 years, women only
- Conditions the study is for
- Neoplasms, Breast
- What is being tested?
- lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 28 Nov 2005to 1 Apr 2009
- 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 20 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
- Life expectancy of ≥16 weeks from the start of lapatinib therapy;
- Signed informed consent obtained from the patient;
- Subjects must have histologically confirmed breast cancer with advanced (Stage IIIb, IIIc with T4 lesion) or metastatic disease (including recurrent patients);
- Subjects must meet the following criteria regarding prior therapy:
- Anthracyclines, taxanes:
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- If anthracycline- and taxane-containing regimens are administered sequentially;
- Subjects should have been provided with at least 2 cycles each and at least 4 cycles in total.
- If anthracycline- and taxane-containing regimen are administered concurrently;
- Subjects should have been provided with at least 4 cycles in total. or
- Subjects should have been provided with at least 2 cycles in total and provided progressive disease occurred.
- If anthracycline- and taxane-containing regimen are administered separately;
- Subjects should have been provided with at least 4 cycles each. or
- Subjects should have been provided with at least 2 cycles each and provided progressive disease occurred each regimen.
- Trastuzumab:
- Prior treatment must contain trastuzumab alone or in combination with other chemotherapy for at least 6 weeks of standard doses.
- Subjects must meet the following criteria regarding ErbB2 expression (defined by the following status before undergoing trastuzumab therapy.)
- Patients with ErbB2 overexpression:
- 3+ by IHC, or FISH+
- 2+ by IHC and FISH+ are also eligible. However, patients with "2+ by IHC" who have previously been treated with trastuzumab should undergo FISH before study entry, if they have not had this test performed before, and are considered eligible only if their tumours are categorised as FISH+.
- Documentation of tumor progression or relapse after the most recent treatment is required.
- Archived tumor tissue must be available to compare tumor response with intra-tumoral expression levels of biomarkers (ErbB1 and ErbB2).
- Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors); (See "6.3. Efficacy")
- A female, ≥20 and ≤74 years (at the time of giving consent), is eligible to enter and participate in this study if she is of:
- Non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are post-menopausal, i.e., at least 1 year has past since the last menstrual period); or is
- The subject has a negative serum pregnancy test at screening, and agrees to one of the following from 2 weeks prior to administration of the first dose of lapatinib until 28 days after the final dose of lapatinib＊.
- Complete abstinence from intercourse:
- Consistent and correct use of one of the following acceptable methods of birth control:
- Injectable progestogen;
- Any intrauterine device (IUD);
- Oral contraceptives (either combined or Progestogen only);
- Barrier methods including diaphragm or condom with a spermicide.
- At least 3 weeks since the last dose of prior last chemotherapy, immunotherapy, biologic therapy, hormonal therapy, or radiotherapy (except for local radiation therapy to pain relief) for cancer or since the date of completion of surgery (except for minor surgical procedures) before beginning treatment with lapatinib, except for trastuzumab which must be discontinued at least 2 weeks prior to beginning of study drug. Subjects must have recovered or stabilized sufficiently from side effects associated with prior therapy;
- Prior to enrollment, radiation therapy is allowed to a limited field (e.g. painful bone mets, painful lumps), if it is not the sole site of measurable and/or assessable disease. Patients must have completed treatment and adequately recovered, in particular from bone marrow suppression.
- Subjects who are not on bisphosphonate therapy. Bisphosphonates initiated prior to study medication are allowed; however, initiation of bisphosphonate following the first dose of study medication is not allowed. Prophylactic use of bisphosphonates is only permitted for treatment of osteoporosis.
- Subjects with stable CNS metastasis (asymptomatic and off systemic steroids and anticonvulsants for at least 3 months) are also eligible;
- ECOG Performance Status of 0 to 2;
- Able to swallow and retain oral medication;
- Left ventricular ejection fraction (LVEF), measured by echocardiogram (ECHO), above the institutional's lower limit of normal (LVEF of ≥50% in such case as normal range of LVEF is not provided by institution).
- Subjects must have adequate organ function as defined below:
- Myelofunction:
- Neutrophil count ≥1500 /mm3 Hemoglobin ≥9 g/dL (at least 2 weeks after blood transfusion if needed) Platelet count ≥100,000 /mm3
- Hepatic function:
- Albumin ≤2.5 g/dL Total bilirubin ≤1.5xULN AST, ALT: ≤3xULN (without liver metastases), ≤5xULN (if documented liver metastases)
- Renal function:
- Serum creatinine ≤1.5 mg/dL, or creatinine clearance ≤40 mL/min (calculated by the Cockcroft and Gault Method)
- Subjects who can visit the hospital once weekly (±3 days) at least in the first month after the start of lapatinib therapy and then every 4 weeks (±1 week) until the last assessment.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Pregnant or lactating females;
- Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
- History of other malignancy. 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 disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety * [* ≥Grade 3 (according to NCI-CTCAE Version 3.0), as a general rule];
- Active or uncontrolled infection;
Show all 13Show fewer
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
- Known history of or clinical evidence of leptomeningeal carcinomatosis;
- Participated in a clinical study within the past 28 days of the first dose of lapatinib;
- Prior therapy with an ErbB1inhibitor (e.g., gefinitib) and/or ErbB2 inhibitor other than trastuzumab;
- Has taken/received prohibited inhibitors (including foods) of CYP3A4 within 7 days prior to the first dose of study medication or has taken/received prohibited inducers inducers (including foods) of CYP3A4 within 14 days prior to the first dose of study medication(Refer to Appendix 7).
- The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients
- Patients ineligible for participation in the study in the judgment of the investigator/sub investigator.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Japan8 sites
GSK Investigational Site
Ehime, 791-0280
GSK Investigational Site
Fukuoka, 814-0180
GSK Investigational Site
Kanagawa, 241-0815
GSK Investigational Site
Okayama, 701-0192
GSK Investigational Site
Tochigi, 329-0498
GSK Investigational Site
Tokyo, 104-0045
GSK Investigational Site
Tokyo, 113-8677
GSK Investigational Site
Tokyo, 135-8550
Location not given1 site
GSK Investigational Site
About this study
Official title: Phase II Clinical Study of Lapatinib (GW572016) in Patients With ErbB2 Over - Expressing Advanced or Metastatic Breast Cancer
This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.
- Conditions
- Neoplasms, Breast
- Being tested
- lapatinib
- Keywords
- Stage IV breast cancer, Herceptin, metastatic breast cancer, ErbB1, ErbB2, trastuzumab, lapatinib
- 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
Lapatinib 1500mg QD
| Study group | Role | What they receive |
|---|---|---|
| Lapatinb | Experimental | Lapatinib 1500mg QD Receives: Drug: lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Tumor Response
Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.
Measured: Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.
Secondary outcomes (17)
Duration of Response
Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer.
Measured: First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.
Time to Progression
Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions.
Measured: Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.
Clinical Benefit
Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks.
Measured: Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.
Time to Response
Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first).
Measured: Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.
4-month Progression Free Survival
The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing.
Measured: Baseline to Month 4 (Week 16)
6-month Progression Free Survival
The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing.
Measured: Baseline to Month 6 (Week 24)
Overall Survival
Overall survival was measured as the time between the start of dosing until death, regardless of cause.
Measured: Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death.
Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants
Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean p-BAD H Score for All Participants
Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean Bcl-2 H Score for All Participants
Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants
Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants
Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants
Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean Heregulin H Score for All Participants
Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants
Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean Survivin H Score for All Participants
Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants
Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Measured: Tumor samples taken at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study start28 Nov 2005
- Primary completion1 Apr 2009
- Study completion1 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, BreastStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320411
- Sponsor's protocol ID
- EGF104911
- Status last verified
- Aug 2018
- First submitted
- 1 May 2006
- Last updated
- 31 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Toi M, Iwata H, Fujiwara Y, Ito Y, Nakamura S, Tokuda Y, Taguchi T, Rai Y, Aogi K, Arai T, Watanabe J, Wakamatsu T, Katsura K, Ellis CE, Gagnon RC, Allen KE, Sasaki Y, Takashima S. Lapatinib monotherapy in patients with relapsed, advanced, or metastatic breast cancer: efficacy, safety, and biomarker results from Japanese patients phase II studies. Br J Cancer. 2009 Nov 17;101(10):1676-82. doi: 10.1038/sj.bjc.6605343. Epub 2009 Oct 20.
PubMed 19844234
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Lapatinib (GW572016) in Patients With ErbB2 Over - Expressing Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00320411
- Acronym / sponsor ID
- EGF104911
- Conditions
- Neoplasms, Breast
- Keywords
- Stage IV breast cancer, Herceptin, metastatic breast cancer, ErbB1, ErbB2, trastuzumab, lapatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2005
- Primary completion
- 1 Apr 2009 (actual)
- Study completion
- 1 Apr 2009 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Posted 14 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lapatinb | Experimental | Drug: lapatinibLapatinib 1500mg QD |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (47 listed)
- A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
- Life expectancy of ≥16 weeks from the start of lapatinib therapy;
- Signed informed consent obtained from the patient;
- Subjects must have histologically confirmed breast cancer with advanced (Stage IIIb, IIIc with T4 lesion) or metastatic disease (including recurrent patients);
- Subjects must meet the following criteria regarding prior therapy:
Key exclusion criteria (13 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Pregnant or lactating females;
- Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
- History of other malignancy. 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 disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety * [* ≥Grade 3 (according to NCI-CTCAE Version 3.0), as a general rule];
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 |
|---|---|---|
| lapatinibLapatinib 1500mg QD | Drug | Lapatinb |
Primary outcome
Overall Tumor Response
Time frame: Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.
Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.
17 secondary outcomes
Duration of Response
Time frame: First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.
Time to Progression
Time frame: Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.
Clinical Benefit
Time frame: Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.
Time to Response
Time frame: Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.
4-month Progression Free Survival
Time frame: Baseline to Month 4 (Week 16)
6-month Progression Free Survival
Time frame: Baseline to Month 6 (Week 24)
Overall Survival
Time frame: Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death.
Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean p-BAD H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean Bcl-2 H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean Heregulin H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean Survivin H Score for All Participants
Time frame: Tumor samples taken at baseline
Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants
Time frame: Tumor samples taken at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19844234Toi M, Iwata H, Fujiwara Y, Ito Y, Nakamura S, Tokuda Y, Taguchi T, Rai Y, Aogi K, Arai T, Watanabe J, Wakamatsu T, Katsura K, Ellis CE, Gagnon RC, Allen KE, Sasaki Y, Takashima S. Lapatinib monotherapy in patients with relapsed, advanced, or metastatic breast cancer: efficacy, safety, and biomarker results from Japanese patients phase II studies. Br J Cancer. 2009 Nov 17;101(10):1676-82. doi: 10.1038/sj.bjc.6605343. Epub 2009 Oct 20.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
9 sites in 2 countries: see every site and its status.
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 9 sites in 2 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 47 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: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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 14 Dec 2009). 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: Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.). 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 NCT00320411, 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 31 Jan 2019.