Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib

Completed

• Conditions: Breast Neoplasm

• Registration Number: NCT02056080
• Lead Sponsor: MedSIR

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response rate assessed by RECIST criteria	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 Outcome Measures

Name	Time	Method
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	The progression will be evaluated by RECIST v 1.1.
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	Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4
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	clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks
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	The progression will be evaluated by RECIST v 1.1.