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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01782651
First received: January 31, 2013
Last updated: July 3, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to progression (TTP) expressed in weeks and months [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: December 2014
Estimated Primary Completion Date: July 2014 (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
Study Population

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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782651

Locations
Hungary
GSK Investigational Site
Budapest, Hungary, 1082
GSK Investigational Site
Budapest, Hungary, 1115
GSK Investigational Site
Budapest, Hungary, 1125
GSK Investigational Site
Budapest, Hungary, 1145
GSK Investigational Site
Budapest, Hungary, 1032
GSK Investigational Site
Budapest, Hungary, 1122
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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: July 3, 2014
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Breast Cancer
HER2 positive
treatment patterns

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Lapatinib
Mitogens
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014