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Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years (LongHer)

This study has been completed.
Sponsor:
Collaborator:
Roche Farma, S.A
Information provided by (Responsible Party):
Asociación para el Progreso de la Oncología en Málaga
ClinicalTrials.gov Identifier:
NCT01433926
First received: September 13, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted

September 13, 2011
September 13, 2011
September 2009
March 2011   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years
Observational, Cross-sectional Study to Analyze the Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete Remission, Partial Remission or Stabilization of Disease During More Than 3 Years

Main objective: To analyze the clinical and biological characteristics of patients with disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete remission, partial or stable disease for a period exceeding 3 years.

In addition, there will be a sub-genetic analysis of patients in whom there is availability a sample of primary tumor preserved in paraffin. This sub-analysis will not interfere with routine clinical practice, as the tumor samples based on which will be held on genetic profile, have been preserved in paraffin was extracted from the primary tumor to the patient.

SECONDARY OBJECTIVES:

  • To determine the frequency of patients achieving partial response or stable disease for a period exceeding 3 years.
  • Know the time to complete or partial remission or to achieve stabilization of the disease.
  • Know the length of the complete or partial remission or time to disease stabilization of patients.
  • Knowing the pattern of treatment that has achieved complete or partial remission or stabilization of disease and duration.
  • Knowledge of overall survival.
  • Knowing the toxicity of prolonged administration of trastuzumab.
  • Identify the primary tumor genes HER-2 associated with such prolonged responses.

The source document will be in all cases the clinical history and in the case of patients selected for the sub-genetic analysis, the report resulting from it.

The study is carried out by filling a notebook of electronic data collection that gathers all available information contained in medical records.

The sub-genetic analysis will be performed at the Hospital de la Paz. Both, the processing of samples and conducting the analysis using qRT-PCR, will be performed in this hospital.

All data are stored, ensuring the confidentiality, security and authenticity .The forms must be reviewed by the monitor.

Once recorded the data, the database will be revised and monitored to submit those records in which there are inconsistencies or missing information . Following the closure of the database will be a report which will present the results of the analysis of the data.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

primary tumor, preserved in paraffin

Non-Probability Sample

Women with disseminated breast cancer, HER-2 3+ or FISH+.

HER-2 Positive Breast Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
September 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Women older than 18.
  2. Patients with disseminated breast cancer with overexpression of HER-2 (IHC 3 + or FISH +).
  3. Patients who have been treated with trastuzumab (Herceptin ®).
  4. Complete remission, partial or stable disease for a period exceeding 3 years, except for exclusive cerebral progression.
  5. Patients who have given their written informed consent.

Exclusion Criteria:

1- Patients with remission achieved with surgery or less than three months of treatment with trastuzumab.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01433926
LongHer
Yes
Asociación para el Progreso de la Oncología en Málaga
Asociación para el Progreso de la Oncología en Málaga
Roche Farma, S.A
Study Chair: Emilio Alba Hospital Virgen de la Victoria
Asociación para el Progreso de la Oncología en Málaga
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP