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)

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

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

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response rate assessed by RECIST criteria	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	Up to 24 weeks from the first clinical response rate assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib	The progression will be evaluated by RECIST v 1.1.	Up to one year from the last dose of TL
To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines.	clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks	Up to 24 weeks from the last dose of TL
To compare the time to progression of different subpopulations according to the biological characteristics of the tumor.	The progression will be evaluated by RECIST v 1.1.	Up to one year from the last dose of TL
To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit	Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4	Up to one year from the last dose of TL

Collaborators and Investigators

• Sponsor: MedSIR
• Investigators: Principal Investigator: Joaquin Gávila, MD, Valencia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Breast Neoplasm; Antibodies, monoclonal; Antineoplastic agent; Receptor,HER2; Trastuzumab, Lapatinib; Protein kinase inhibitors; quinazolines
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MED-DBL-2012-01