Last updated: 11/07/2018 11:12:33
Indirect Treatment Comparison to Inform the Evaluation of the Cost-Effectiveness of Lapatinib plus Letrozole for First-Line Treatment of Post-Menopausal Women with Hormone Receptor Positive and HER-2 Positive Metastatic Breast Cancer from Canadian Societal and Healthcare System Perspectives
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Indirect Treatment Comparison to Inform the Evaluation of the Cost-Effectiveness of Lapatinib plus Letrozole for First-Line Treatment of Post-Menopausal Women with Hormone Receptor Positive and HER-2 Positive Metastatic Breast Cancer from Canadian Societal and Healthcare System Perspectives
Trial description: While the EGF30008 trial provides evidence of the clinical benefits of lapatinib-letrozole versus letrozole in patients with HER2+ and HR+ MBC, it did not assess the effectiveness of lapatinib-letrozole with other widely used treatment (e.g., trastuzumab-anastrozole, anastrozole, other hormonal and chemotherapies, alone or in combination). Nor did it address the cost-effectiveness of combined hormonal and ErbB-targeted therapy with lapatinib-letrozole. Such information is required by health care decision-making authorities in Canada in their deliberations regarding pricing, reimbursement, and access to novel therapies. In this study we will apply network meta-analysis techniques to perform an indirect treatment comparisonan of lapatinib-letrozole with other widely used treatments. This will inform the cost-effectiveness analysis of lapatinib-letrozole in patients with HER2+ and HR+ MBC from Canadian societal and healthcare system perspectives.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall Survival
Timeframe: 10 years
Progression Free Survival
Timeframe: 10 years
Secondary outcomes:
Not applicable
Interventions:
Drug: trastuzumab-paclitaxel
Drug: letrozole
Drug: trastuzumab-docetaxel
Drug: lapatinib-letrozole
Drug: anastrozole
Drug: trastuzumab-anastrozole
Enrollment:
0
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Ayman Chit, Mayur Amonkar, Tom Delea, Jordan Amdahl . Cost-effectiveness of lapatinib+letrozole in HER2+, HR+ metastatic breast cancer in Canada. Curr Oncol. 2013;20:e371-387.
Medical condition
Cancer, Neoplasms
Product
lapatinib
Collaborators
None
Study date(s)
June 2011 to November 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
none
- Randomized Controlled Trials
- Females with HR+/- and HER2+/- disease
Inclusion and exclusion criteria
Inclusion criteria:
- Randomized Controlled Trials
- Females with HR+/- and HER2+/- disease
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-28-11
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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