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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

Tracking Information
First Submitted Date January 10, 2014
First Posted Date February 5, 2014
Last Update Posted Date September 9, 2019
Actual Study Start Date January 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 4, 2014)
  • 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.
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Breast Neoplasm
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 4, 2014)
111
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02056080
Other Study ID Numbers MED-DBL-2012-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MedSIR
Study Sponsor MedSIR
Collaborators Not Provided
Investigators
Principal Investigator: Joaquin Gávila, MD Valencia
PRS Account MedSIR
Verification Date September 2019