Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00479856|
Recruitment Status : Terminated (Study was terminated due to difficulty in identifying eligible subjects)
First Posted : May 28, 2007
Results First Posted : June 2, 2010
Last Update Posted : June 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Breast Cancer Neoplasms, Breast||Drug: Lapatinib Drug: Capecitabine Drug: Docetaxel Drug: nab-Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||March 2010|
Experimental: Lapatinib plus Chemotherapy
Lapatinib is administered in combination with one of the following chemotherapies based on the discretion of the investigator : capecitabine, docetaxel or nab-paclitaxel.
Small molecule tyrosine kinase inhibitorDrug: Capecitabine
- 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) ]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.
- Clinical Benefit (CB) [ 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 weeks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason) ]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).
- Duration of Response [ Time Frame: time from first documented evidence of CR or PR until the first documented sign of disease progression or death (approximately 95 weeks) ]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.
- Time to Response (TTR) [ Time Frame: start of treatment until first documented evidence of CR or PR (approximately 95 weeks) ]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.
- Progression-free Survival [ 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 weeks); dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason) ]The time from the start of treatment until the earliest date of disease progression or death due to any cause was measured.
- Number of Participants With the Indicated Serious Adverse Events and Adverse Events [ Time Frame: 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479856
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|