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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer

NCT01273610

Breast Neoplasms HER2/Neu Positive Geriatric Health Services

ACTIVE_NOT_RECRUITING PHASE2

Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

NCT00320385

Neoplasms, Breast

COMPLETED PHASE3

Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

NCT02213042

Neoplasms, Breast

TERMINATED PHASE2

Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine

NCT03025711

Breast Neoplasms

COMPLETED

Lapatinib With Trastuzumab in Treating Patients With HER2-Negative/HER2 Mutant Metastatic Breast Cancer

NCT01557764

Breast Neoplasms

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No