A Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients
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ClinicalTrials.gov Identifier: NCT01161368 |
Recruitment Status
:
Terminated
(poor recruitment)
First Posted
: July 13, 2010
Last Update Posted
: August 13, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | May 27, 2010 | |||
First Posted Date ICMJE | July 13, 2010 | |||
Last Update Posted Date | August 13, 2015 | |||
Study Start Date ICMJE | September 2010 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progressive Free Survival [ Time Frame: 4 years ] Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01161368 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients | |||
Official Title ICMJE | A Phase II Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients Pretreated With Chemotherapy or Hormonal Treatment in Combination With Lapatinib for Metastatic Disease | |||
Brief Summary | The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy) including lapatinib and presenting with tumor progression. Primary objective is to assess the efficacy with respect to the percentage of patients surviving without disease progression as assessed by RECIST criteria. Secondary objectives are to assess the efficacy of the study treatment with respect to the objective response rates as assessed by RECIST criteria version 1.1, the overall survival and to evaluate the safety profile of the combination by recording the adverse events and abnormal laboratory values associated with the study treatments. The main efficacy endpoints will be investigated both for the intent-to-treat (ITT) population and the per-protocol (PP) population. |
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Detailed Description | The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive breast cancer pretreated with a combination therapy (chemotherapy, hormonal therapy) including lapatinib for metastatic disease. The sample size is not based on statistical consideration. Thirty 30 patients are considered appropriate for a phase II study to gain first information on the efficacy and safety of the study treatment in the study indication. Only descriptive statistical methods will be used to summarize the study results. Kaplan-Meier estimates will be calculated for PFS and OS. Median PFS and OS time and corresponding two sided 95% confidence intervals will be provided. Categorical endpoints will be summarized in frequency tables and 95% confidence intervals will be calculated for the objective response rate (ORR) using RECIST. All safety variables will be summarized descriptively The incidence of adverse events will be summarized by MedDRA terms in a descriptive manner. The progression free survival time (PFS) is the primary efficacy endpoint of the study. Secondary outcomes are overall survival (OS) and objective response rates (ORR) using RECIST. Safety outcomes are adverse events, safety laboratory data, physical examinations, vital signs, LVEF, ECG data and ECOG performance status Definitions: The objective response rate is the rate of subjects with complete response (CR) or partial response (PR). Progression-free survival: The time to progression or death is defined as the time from study entry until the first observation of disease progression or death due to any cause (whichever occurred earlier). Only those death will be considered, which occurs within 84 days of the last tumor assessment or study entry (whichever is later). If a patient has no progression before a clinical cut-off or the death date is beyond the above-mentioned time interval after last tumor assessment, time to progression/death is censored on the date of last tumor assessment or study entry (in case of no post-baseline tumor assessment). Overall survival will be calculated from study entry until death. For patients lost to follow-up, data will be censored at the time the patient was last determined to be alive. As efficacy data of vinorelbine plus lapatinib are not available so far and the current protocol is applied as 2nd or 3rd line therapy for metastatic disease an ORR from 30-40% and a median PFS from 4-6 months is expected. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Breast Cancer | |||
Intervention ICMJE | Drug: Lapatinib, Vinorelbine
Lapatinib 1250mg orally once daily continuously plus Vinorelbine 20 mg/m2 intravenously (IV) once weekly [Days 1 and 8] for 2 weeks, followed by a rest week in a 3-week cycle. |
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Study Arms | Experimental: lapatinib, vinorelbine
Drug: Lapatinib, Vinorelbine Lapatinib 1250mg orally once daily continuously plus Vinorelbine 20 mg/m2 intravenously (IV) once weekly [Days 1 and 8] for 2 weeks, followed by a rest week in a 3-week cycle. Intervention: Drug: Lapatinib, Vinorelbine |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
9 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date | May 2014 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Hungary | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01161368 | |||
Other Study ID Numbers ICMJE | CECOG/BC.1.2.001 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Central European Cooperative Oncology Group | |||
Study Sponsor ICMJE | Central European Cooperative Oncology Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Central European Cooperative Oncology Group | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |