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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)

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ClinicalTrials.gov Identifier: NCT02056080
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Breast Neoplasm

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HER2 positive metastatic breast cancer who progressed to antiHER2 therapy with trastuzumab and / or lapatinib for the metastasic disease and that between January 2005 and December 2011, began treatment with the combination of trastuzumab and lapatinib (TL).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056080


Locations
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Spain
Barcelona, Spain
Córdoba, Spain
Girona, Spain
Jaen, Spain
Madrid, Spain
Pamplona, Spain
Salamanca, Spain
Santiago de Compostela, Spain
Sevilla, Spain
Valencia, Spain
Zaragoza, Spain
Sponsors and Collaborators
MedSIR
Investigators
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Principal Investigator: Joaquin Gávila, MD Valencia
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Responsible Party: MedSIR
ClinicalTrials.gov Identifier: NCT02056080    
Other Study ID Numbers: MED-DBL-2012-01
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Keywords provided by MedSIR:
Breast Neoplasm
Receptor,HER2
Antineoplastic agent
Antibodies, monoclonal
Trastuzumab, Lapatinib
Protein kinase inhibitors
quinazolines
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases