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

N/ACompletedNCT02056080

MedSIR111 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

111

Conditions

Breast Neoplasm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Unnamed facility

Barcelona, Spain

Unnamed facility

Córdoba, Spain

Unnamed facility

Girona, Spain

Unnamed facility

Jaén, Spain

Outcomes

Primary Outcomes

Clinical response rate assessed by RECIST criteria

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

Time frame: Up to 24 weeks from the first clinical response rate assessment

Secondary Outcomes

To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib

The progression will be evaluated by RECIST v 1.1.

Time frame: 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.

clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks

Time frame: 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.

The progression will be evaluated by RECIST v 1.1.

Time frame: 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

Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4

Time frame: Up to one year from the last dose of TL

Data from ClinicalTrials.gov

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