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Completed

NCT Number: NCT02056080

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

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

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

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

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

    The progression will be evaluated by RECIST v 1.1.

  2. To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines.

    Time frame: 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

  3. To compare the time to progression of different subpopulations according to the biological characteristics of the tumor.

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

    The progression will be evaluated by RECIST v 1.1.

  4. To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit

    Time frame: 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

Sponsors and collaborators

Lead sponsor

MedSIR

Other

Registry information

Official study title

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

Acronym: TRASTYVERE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2014
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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