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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 (TRASTYVERE)

M

MedSIR

Status

Completed

Conditions

Breast Neoplasm

Study type

Observational

Funder types

Other

Identifiers

NCT02056080
MED-DBL-2012-01

Details and patient eligibility

About

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

Enrollment

111 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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