Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients

Completed

• Conditions: Neoplasms, Breast
• Interventions: Drug: Lapatinib plus capecitabine

• Registration Number: NCT01782651
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will describe the treatment paradigm used over recent years in the clinical management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in Hungary. This information will provide insight into real-world exposure and adherence to anti-HER2 therapy containing regimens, and improve understanding of the reasons for discontinuation of this therapy.

This is a retrospective, descriptive, cohort study of approximately 180 female patients diagnosed with HER2-positive metastatic breast cancer in Hungary. Patients diagnosed with, or who progressed to, metastatic disease between 01 September 2009 and 01 September 2010 will be included. All patients will be followed until death, loss to follow-up or the end of the study period (30 September 2012). All data will be collected retrospectively from patient medical records.

Descriptive statistics of the demographic and clinical characteristics of HER2+ metastatic breast cancer patients, including sites of metastases, the time from initial breast cancer diagnosis until diagnosis of metastatic disease, and HER2 testing methodology and status of HER2 will be described. Further, descriptive statistics of the proportion of HER2+ metastatic breast cancer patients who received anti-HER2 therapy, the sequencing of different therapies, and the duration of therapies in the metastatic setting will be analysed. Among the subset of women who receive lapatinib plus capecitabine, descriptive statistics of the timing of initiation of lapatinib plus capecitabine in the metastatic treatment pathway, time to treatment discontinuation and time to progression (TTP) on lapatinib plus capecitabine will be calculated. Further, descriptive statistics of the type and duration anti-HER2 therapies used prior to initiation of lapatinib plus capecitabine and, where relevant, after lapatinib+capecitabine will be performed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Study Start: 2014-08
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Female patients aged 18 years or older at diagnosis of, or progression to, metastatic breast cancer
• Patients with a diagnosis of breast cancer with documented metastatic disease and with known date of metastatic disease
• Patients with a histologically confirmed HER2+ breast cancer (HER2 testing procedures per routine institutional practice; no tissue re-sampling will be performed. If conducted at another site, documented results must be available).

Exclusion Criteria

• Patients receiving care for another primary cancer during the study time period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HER2+ metastatic breast cancer patients treated with lapatinib	Lapatinib plus capecitabine	HER2+ metastatic breast cancer patients treated with lapatinib plus capecitabine

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP) expressed in weeks and months	2 years

Secondary Outcome Measures

Name	Time	Method
Time to discontinuation of lapatinib plus capecitabine, expressed in weeks and months.	2 years	Discontinuation will be measured from the initiation of lapatinib plus capecitabine to the date of discontinuation of this regimen due to any reason. Patients still responding to lapatinib plus capecitabine at the end of the Follow up Period will be censored at the date of the last follow-up contact.

Trial Locations

Locations (1)

GSK Investigational Site; 🇭🇺 Debrecen, Hungary