Neoplasms, BreastPhase 2NCT00356811
Lapatinib Combined With Paclitaxel For Patients With First-Line ErbB2-Amplified Metastatic Breast Cancer
A Phase 2 study testing Lapatinib oral tablets and Paclitaxel infusion in people with Neoplasms, Breast, run by GlaxoSmithKline at 13 sites in 4 countries.
Trial summary
This study investigates the safety and efficacy of oral lapatinib in combination with an approved medication, paclitaxel, for patients with ErbB2 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 oral tablets and Paclitaxel infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 13 sitesin 4 countries
- Study dates
- May 2006to Dec 2013
- 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
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Signed informed consent.
- Only females ≥18 years of age will be recruited:
- Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal); or
- Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea (severe), women who are perimenopausal and young women who have begun to menstruate. These subjects must provide a negative serum pregnancy test at Screening and agree to one of the following:
- Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or
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- Consistent and correct use of one of the following acceptable methods of birth control:
- Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject.
- Implants of levonorgestrel.
- Injectable progestogen.
- Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
- Oral contraceptives (either combined or progestogen only).
- Barrier methods, including diaphragm or condom with a spermicide.
- Subjects must have histologically confirmed invasive breast cancer with stage IVdisease;
- Where the disease is restricted to a solitary lesion, the neoplastic nature of the lesion should be confirmed by cytology or histology.
- Subjects whose disease is ER+ and/or PR+ or unknown status will only be included in the study if they meet the following criteria:
- They have symptomatic visceral disease that requires chemotherapy (e.g., patients with liver or lung metastases).
- The disease is considered by the Investigator to be progressing rapidly or lifethreatening.
- Subjects who have received endocrine therapy and who are no longer benefiting from this therapy.
- Documented amplification of ErbB2 defined by FISH in primary or metastatic tumor tissue. Results of FISH testing at local laboratories are acceptable, however, tissue sample must still be sent to Central laboratory where results will be repeated but not used for eligibility criterion.
- If a taxane had been administered in the neoadjuvant or adjuvant setting, progression must have occurred ≥12 months after completion of this treatment.
- Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria [Stephens, 2004; Therasse, 2000].
- Radiotherapy prior to initiation of study medication is allowed to a limited area (e.g., palliative treatment for painful bone metastases), if it is not the sole site of disease. Subject must have completed radiation treatment and recovered from all acute radiation treatment-related toxicities, in particular bone marrow suppression.
- Bisphosphonate therapy for bone metastases is allowed however; treatment must be initiated prior to the first dose of study medication. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted.
- Subjects with stable central nervous system (CNS) metastases (stable for at least 3 months) as confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI)) or leptomeningeal involvement are eligible only if they are not taking oral steroids or enzyme-inducing anticonvulsants.
- Subjects must have a cardiac ejection fraction within institutional range of normal as measured by echocardiogram (or multigated acquisition (MUGA) scan if an echocardiogram cannot be performed or is inconclusive). Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1.
- Considered by the Investigator to have a life expectancy of at least 3 months.
- Able to swallow and retain oral medication.
- Subjects must have new or archived tumor tissue available for analysis.
- Subjects must complete all screening assessments as outlined in the protocol.
- Subject must have adequate organ function as defined in Table 1.
- Table 1 Baseline Laboratory Values for Adequate Organ Function SYSTEM LABORATORY VALUES
- Haematologic
- Absolute neutrophil count ≥1.5 × 10^9/L Haemoglobin ≥9 g/dL Platelets ≥100 × 10^9/L
- Hepatic
- Albumin ≥2.5 g/dL Serum bilirubin
- 1.25 x ULN AST and ALT ≤3 × ULN without liver metastases
- 5 × ULN with documented liver metastases
- Renal
- Serum Creatinine1 ≤2.0 mg/dL
- OR - Calculate Creatinine Clearance1 ≥40 mL/min
- Calculated by the Cockcroft and Gault Method. ALT = alanine aminotransferase; AST = aspartate aminotransferase
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.
- Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy for metastatic disease.
- Prior therapy with ErbB1 and/or ErbB2 inhibitors.
- Concurrent anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy) while taking study medication.
- Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
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- Peripheral neuropathy of grade 2 or greater.
- 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. 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 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.
- Active or uncontrolled infection.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
- Concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents.
- Used an investigational drug within 30 days or five half-lives, whichever is longer, preceding the first dose of investigational treatment.
- The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients and those related to paclitaxel or excipients.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Russia5 sites
GSK Investigational Site
Moscow, 115 478
GSK Investigational Site
Moscow, 117997
GSK Investigational Site
Moscow, 129 128
GSK Investigational Site
Saint Petersburg, 197022
GSK Investigational Site
Saint Petersburg, 197758
Poland4 sites
GSK Investigational Site
Krakow, 31-115
GSK Investigational Site
Olsztyn, 10-228
GSK Investigational Site
Olsztyn, 10-699
GSK Investigational Site
Warsaw, 02-781
Latvia3 sites
GSK Investigational Site
Liepāja, LV3401
GSK Investigational Site
Riga, LV 1002
GSK Investigational Site
Riga, LV 1079
About this study
Official title: An Open-label, Single-arm, Multi-centre, Phase II Study of Oral Lapatinib in Combination With Paclitaxel as First-line Treatment for ErbB2-amplified Metastatic Breast Cancer Patients
This study investigates the safety and efficacy of oral lapatinib in combination with an approved medication, paclitaxel, for patients with ErbB2 metastatic breast cancer.
- Conditions
- Neoplasms, Breast
- Being tested
- Lapatinib oral tablets, Paclitaxel infusion
- Keywords
- Lapatinib, Metastatic breast cancer, Paclitaxel, ErbB2-amplification, GW572016
- 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 oral tabletsDrug
Also called Tykerb/ Tyverb
Lapatinib will be given as tablets contain 410 mg of lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib free base per tablet. Subjects will be given a 4 week supply of lapatinib tables and instructed to take 6 tablets daily (1500 mg daily dose) orally at the same time each day. Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Paclitaxel infusionDrug
Also called Taxol
Subjects will receive weekly paclitaxel (80 mg/m2 IV for 3 weeks in a 4 week cycle). Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent. Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent. Receives: Drug: Lapatinib oral tablets; Drug: Paclitaxel infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 CR or PR, per Response Evaulation Criteria in Solid Tumors (RECIST). The 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 one or more 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 first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)
Secondary outcomes (9)
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 CR or PR, per RECIST. The 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 Investigator. 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. 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 first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)
Duration of Response (DoR), as Assessed by the IRC
DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the 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 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 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. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant 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 Week 86)
Duration of Response (DoR), as Assessed by the Investigator
DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the 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 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 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. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant 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 Week 86)
Time to Response, as Assessed by the IRC
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 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 randomization until the first documented evidence of a PR or CR (up to Week 86)
Time to Response, as Assessed by the 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 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 randomization until the first documented evidence of a PR or CR (up to Week 86)
Time to Progression, as Assessed by the IRC and the Investigator
Time to progression is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to breast cancer, whichever occurs first. Participents who did not progress or die were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. 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. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.
Measured: From the start date of treatment until the date of radiological disease progression or the date of death due to breast cancer (up to Week 86)
Progression-free Survival, as Assessed by the IRC and the Investigator
Progression-free survival is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to any cause, whichever occurs first. Participants who did not progress in their disease were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. 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. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.
Measured: From the start date of treatment until the date of radiological disease progression or death due to any cause, whichever occurs first (up to Week 86)
Overall Survival
Overall survival is defined as the interval between the date of treatment start and the date of death due to any cause. For participants who did not die, follow-up was censored as the date of last contact. For participants who did not die, follow-up was censored at the date of last contact.
Measured: From the date of the first dose until the date of death due to any cause (up to Week 86)
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.
Measured: From the start of study medication until 28 days after the last dose (up to Study Week 381)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2008
- Study completionDec 2013
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 (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 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
- NCT00356811
- Sponsor's protocol ID
- EGF105764
- Status last verified
- May 2014
- First submitted
- 25 Jul 2006
- Last updated
- 21 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jagiello-Gruszfeld A, Tjulandin Sergei S, Dobrovolskaya N et al, Lapatinib (L) with weekly paclitaxel (P) as first-line therapy for patients (pts) with HER2+ metastatic breast cancer (MBC). The 31st Annual San Antonio Breast Cancer Symposium; San Antonio TX: December 10-14 2008. Abstract 3145.
Jagiello-Gruszfeld A, Tjulandin S, Dobrovolskaya N, Manikhas A, Pienkowski T, DeSilvio M, Ridderheim M, Abbey R. A single-arm phase II trial of first-line paclitaxel in combination with lapatinib in HER2-overexpressing metastatic breast cancer. Oncology. 2010;79(1-2):129-35. doi: 10.1159/000318043. Epub 2010 Nov 22.
PubMed 21088439
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multi-centre, Phase II Study of Oral Lapatinib in Combination With Paclitaxel as First-line Treatment for ErbB2-amplified Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00356811
- Acronym / sponsor ID
- EGF105764
- Conditions
- Neoplasms, Breast
- Keywords
- Lapatinib, Metastatic breast cancer, Paclitaxel, ErbB2-amplification, GW572016
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jul 2006 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the safety and efficacy of oral lapatinib in combination with an approved medication, paclitaxel, for patients with ErbB2 metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Lapatinib oral tablets, Drug: Paclitaxel infusionSubjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent. Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Signed informed consent.
- Only females ≥18 years of age will be recruited:
- Subjects must have histologically confirmed invasive breast cancer with stage IVdisease;
- Subjects whose disease is ER+ and/or PR+ or unknown status will only be included in the study if they meet the following criteria:
Key exclusion criteria (16 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Pregnant or lactating females.
- Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy for metastatic disease.
- Prior therapy with ErbB1 and/or ErbB2 inhibitors.
- Concurrent anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy) while taking study medication.
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 |
|---|---|---|
| Lapatinib oral tabletsAlso: Tykerb/ TyverbLapatinib will be given as tablets contain 410 mg of lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib free base per tablet. Subjects will be given a 4 week supply of lapatinib tables and instructed to take 6 tablets daily (1500 mg daily dose) orally at the same time each day. Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent. | Drug | Single arm |
| Paclitaxel infusionAlso: TaxolSubjects will receive weekly paclitaxel (80 mg/m2 IV for 3 weeks in a 4 week cycle). Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent. | Drug | Single arm |
Primary outcome
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 first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)
OR is defined as the number of participants achieving either a CR or PR, per Response Evaulation Criteria in Solid Tumors (RECIST). The 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 one or more 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.
9 secondary outcomes
Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator
Time frame: From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)
Duration of Response (DoR), as Assessed by the IRC
Time frame: 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 Week 86)
Duration of Response (DoR), as Assessed by the Investigator
Time frame: 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 Week 86)
Time to Response, as Assessed by the IRC
Time frame: From randomization until the first documented evidence of a PR or CR (up to Week 86)
Time to Response, as Assessed by the Investigator
Time frame: From randomization until the first documented evidence of a PR or CR (up to Week 86)
Time to Progression, as Assessed by the IRC and the Investigator
Time frame: From the start date of treatment until the date of radiological disease progression or the date of death due to breast cancer (up to Week 86)
Progression-free Survival, as Assessed by the IRC and the Investigator
Time frame: From the start date of treatment until the date of radiological disease progression or death due to any cause, whichever occurs first (up to Week 86)
Overall Survival
Time frame: From the date of the first dose until the date of death due to any cause (up to Week 86)
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Time frame: From the start of study medication until 28 days after the last dose (up to Study Week 381)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundJagiello-Gruszfeld A, Tjulandin Sergei S, Dobrovolskaya N et al, Lapatinib (L) with weekly paclitaxel (P) as first-line therapy for patients (pts) with HER2+ metastatic breast cancer (MBC). The 31st Annual San Antonio Breast Cancer Symposium; San Antonio TX: December 10-14 2008. Abstract 3145.
- Background: PubMed 21088439Jagiello-Gruszfeld A, Tjulandin S, Dobrovolskaya N, Manikhas A, Pienkowski T, DeSilvio M, Ridderheim M, Abbey R. A single-arm phase II trial of first-line paclitaxel in combination with lapatinib in HER2-overexpressing metastatic breast cancer. Oncology. 2010;79(1-2):129-35. doi: 10.1159/000318043. Epub 2010 Nov 22.
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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
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lapatinib oral tablets and Paclitaxel infusion in people with Neoplasms, Breast, run by GlaxoSmithKline at 13 sites in 4 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 43 inclusion and 16 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 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia, Poland, Latvia, Romania. 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 21 Jul 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 first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)). 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 NCT00356811, which also lists 2 linked publications.
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 21 Jul 2014.