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

Breast Neoplasm Clinical Trial

— TRASTYVERE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056080
• Other study ID #: MED-DBL-2012-01
• Status: Completed
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2019
• Source: MedSIR
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedSIR

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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