Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neoplasms, Breast |
Drug: Lapatinib plus capecitabine |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients |
- Time to progression (TTP) expressed in weeks and months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Time to discontinuation of lapatinib plus capecitabine, expressed in weeks and months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 1 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
HER2+ metastatic breast cancer patients treated with lapatinib
HER2+ metastatic breast cancer patients treated with lapatinib plus capecitabine
|
Drug: Lapatinib plus capecitabine
Lapatinib plus capecitabine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
It is planned to capture data on approximately 180 patients with HER2-positive metastatic breast cancer in about 20 medical centres 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).
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.
Contacts and Locations| Hungary | |
| GSK Investigational Site | |
| Budapest, Hungary, 1082 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1122 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1032 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1125 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1145 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1115 | |
| GSK Investigational Site | |
| Debrecen, Hungary, H-4032 | |
| GSK Investigational Site | |
| Gyula, Hungary, H-5700 | |
| GSK Investigational Site | |
| Kaposvár, Hungary, 7400 | |
| GSK Investigational Site | |
| Kistarcsa, Hungary, 2143 | |
| GSK Investigational Site | |
| Miskolc, Hungary, 3526 | |
| GSK Investigational Site | |
| Nyíregyháza, Hungary, 4400 | |
| GSK Investigational Site | |
| Pécs, Hungary, 7624 | |
| GSK Investigational Site | |
| Szeged, Hungary, 6720 | |
| GSK Investigational Site | |
| Szolnok, Hungary, 5004 | |
| GSK Investigational Site | |
| Székesfehérvár, Hungary, 8001 | |
| GSK Investigational Site | |
| Tatabánya, Hungary, 2800 | |
| GSK Investigational Site | |
| Veszprém, Hungary, 8200 | |
| GSK Investigational Site | |
| Zalaegerszeg, Hungary, H-8900 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01782651 History of Changes |
| Other Study ID Numbers: | 116450 |
| Study First Received: | January 31, 2013 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
Breast Cancer HER2 positive treatment patterns |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Mitogens Capecitabine Lapatinib Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013