Clinical trial NCT02056080: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasm
Keywords: Breast Neoplasm
Receptor,HER2
Antineoplastic agent
Antibodies, monoclonal
Trastuzumab, Lapatinib
Protein kinase inhibitors
quinazolines
Lead sponsor: MedSIR
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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


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.

Primary outcomes:
measure: Clinical response rate assessed by RECIST criteria
timeFrame: Up to 24 weeks from the first clinical response rate assessment
Secondary outcomes:
measure: To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib
timeFrame: Up to one year from the last dose of TL
measure: To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines.
timeFrame: Up to 24 weeks from the last dose of TL
measure: To compare the time to progression of different subpopulations according to the biological characteristics of the tumor.
timeFrame: Up to one year from the last dose of TL
measure: To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit
timeFrame: Up to one year from the last dose of TL
Other outcomes:
Locations:
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Girona
country: Spain
city: Jaen
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Salamanca
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Valencia
name: Joaquin Gávila, MD
role: PRINCIPAL_INVESTIGATOR
References: