NCT02056080CompletedNot Applicable
Observational, Retrospective and Multicenter Study to Evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib
MedSIR0 sites111 target enrollmentStarted: January 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 111
- Primary Endpoint
- Clinical response rate assessed by RECIST criteria
Study Overview
Brief Summary
A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of metastatic breast cancer HER2-positive phenotype (confirmed by IHC 3 + or FISH positive)
- •Older than 18 years
- •Progressed to at least one prior treatment line for MBC with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes
- •Having the patient's complete medical history that contains all lines antiHER2 therapy treatment
- •Being a patient who initiated the combination of trastuzumab and lapatinib between January 2005 and December 2011
- •Inform the patient and get the signature of the informed consent
Exclusion Criteria
- •Not having phenotypic classification of the tumor by IHC or FISH test for HER2
- •Being a patient with HER2-negative phenotype(FISH negative or IHC in range [0-2 +] without FISH)
- •Being a patient who received the trastuzumab and/or lapatinib treatment (TL) in combination with chemotherapy
- •Being a patient who, since January 2012, began TL therapy for metastatic disease.
Outcomes
Primary Outcomes
Clinical response rate assessed by RECIST criteria
Time Frame: Up to 24 weeks from the first clinical response rate assessment
clinical benefit rate (CBR): defined as the percentage of patients who achieved an objective response (CR or PR) or tumor stabilization for at least 24 weeks or more during the period of treatment with the combination TL. This variable will be assessed by RECIST v 1.1
Secondary Outcomes
- To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib(Up to one year from the last dose of TL)
- To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit(Up to one year from the last dose of TL)
- To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines.(Up to 24 weeks from the last dose of TL)
- To compare the time to progression of different subpopulations according to the biological characteristics of the tumor.(Up to one year from the last dose of TL)
Investigators
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