Last updated: 11/07/2018 10:33:57

Retrospective Study of the Prevalence, Predictors, and Consequences of Non-Adherence with Lapatinib in Women with Metastatic Breast Cancer Who Were Previously Treated with Trastuzumab

GSK study ID
116548
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Retrospective Study of the Prevalence, Predictors, and Consequences of Non-Adherence with Lapatinib in Women with Metastatic Breast Cancer Who Were Previously Treated with Trastuzumab
Trial description: Controlled clinical trials have shown that lapatinib is an efficacious treatment for human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer in women. However, less is known about the effectiveness of lapatinib in a real-world setting. Adherence with prescribed treatment in clinical practice is often poorer than adherence in controlled trials, as patients are typically monitored less frequently. And, although oral anti-cancer therapies, such as lapatinib, may have advantages in terms of patient convenience and savings in administration costs compared with medications that must be infused, oral therapies may pose particular challenges with respect to adherence in clinical practice.
The objective of this retrospective observational study is to describe the prevalence, predictors, and consequences of non-adherence with lapatinib in women with metastatic breast cancer who were previously treated with trastuzumab in a real world setting. All analyses will be considered hypothesis generating.
Data for this project will be obtained from the Thomson MedStat MarketScan® Commercial Claims and Encounters (CCAE) Database and the Medicare Supplemental and Coordination of Benefits (MDCR) Database. In total, over the period of study, the two databases contain healthcare claims data for over 50 million persons, with an average of three to five years of follow-up.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Adherence

Timeframe: During the lapitinib treatment period. The lapatinib treatment period varies by participant. Data from January 2000 through March 2010 will be evaluated.

Descriptive results for lapatinib treatment patterns

Timeframe: During the lapitinib treatement period. The lapatinib treatment period varies by participant. Data from January 2000 through March 2010 will be evaluated.

Secondary outcomes:

Predictors of non-adherence

Timeframe: The laptinib treatment period and the post-lapatinib treatment period. Data from January 2000 through March 2010 will be included. The lapatinib treatment period and the post-lapatinib treatment period vary by participant.

Mean healthcare costs

Timeframe: Per month during the lapitinib treatment period and in the post-lapitinib treatment period. Data from January 2000 through March 2010 will be included. The lapatinib treatment period and the post-lapatinib treatment period vary by participant.

Measure of time-to-event

Timeframe: During the laptinib treatment period and the post-lapatinib treatment period. Data from January 2000 through March 2010 will be included. The lapatinib treatment period and the post-lapatinib treatment period vary by participant.

Total healthcare utilization

Timeframe: Per month during the lapitinib treatment period and in the post-lapitinib treatment period. Data from January 2000 through March 2010 will be included. The lapatinib treatment period and the post-lapatinib treatment period vary by participant.

Association between non-adherence and healthcare utilization and costs

Timeframe: During the laptinib treatment period and the post-lapatinib treatment period. Data from January 2000 through March 2010 will be included. The lapatinib treatment period and the post-lapatinib treatment period vary by participant.

Interventions:
  • Drug: Lapatinib following trastuzumab
    • Enrollment:
    666
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Delea TE, Kartashov A, Sharma PP. Retrospective Study of the Prevalence, Predictors, and Consequences of Non-Adherence with Lapatinib in Women with Metastatic Breast Cancer Who Were Previously Treated with Trastuzumab. J Pharm Technol. 2014;30:21-30
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    June 2011 to December 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Female gender
    • Age 18 years or older
    • Male sex
    • Age less than 18 years as of index date
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Female gender
    • Age 18 years or older
    • At least twelve months of continuous health plan eligibility prior to index date (date of first claim = ”index date”)
    • At least three months of continuous health plan eligibility from index date to end of study period
    • One or more claims for lapatinib (NDC 00173075200) during the study period
    • One or more claims for trastuzumab (HCPSCS J9355 or NDC 50242013460, 50242013468, 50242005656, or 63552047001) during the study period; One or more claims with a diagnosis of breast cancer during the study period (International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code 174.xx: Malignant neoplasms ICD-9-CM codes 238.3x, 239.3x, V10)
    • One or more claims with a diagnosis of distant metastases during the study period; distant metastases will be identified based on the following ICD-9-CM codes: 155.xx, 162.xx, 170.xx, 191.xx, 192.xx, 196.xx
    • Secondary and unspecified malignant neoplasm of lymph nodes; ICD-9-CM (197.xx, 198.xx, 199.xx)
    Exclusion criteria:
    • Male sex
    • Age less than 18 years as of index date
    • Less than twelve months of continuous eligibility prior to index date
    • Less than three months from index date to end of study period
    • No claims for trastuzumab prior to first claim for lapatinib
    • No claims for trastuzumab after first claim for distant metastases
    • Less than two claims occurring on different days (“claim days”) for lapatinib
    • Missing or ambiguous data on claims or enrollment information

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-30-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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