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)

• ClinicalTrials.gov Identifier: NCT02056080
• Recruitment Status: Completed
• First Posted: February 5, 2014
• Last Update Posted: September 9, 2019
• Sponsor: MedSIR
• 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

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

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

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