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

HER-2 Positive Breast Cancer Clinical Trial

— LongHer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433926
• Other study ID #: LongHer
• Status: Completed
• Phase: N/A
• First received: September 13, 2011
• Last updated: September 13, 2011
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Asociación para el Progreso de la Oncología en Málaga
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Neoplasms
• HER-2 Positive Breast Cancer

Locations

Country	Name	City	State
Spain	Hospital oncológico de Galicia	A Coruña
Spain	Hospital Príncipe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital de Alcoy Virgen de los Lirios	Alcoy	Alicante
Spain	Hospital Punta de Europa	Algeciras	Cádiz
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital General Yagüe	Burgos
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital de Getafe	Getafe	Madrid
Spain	Hospital Clínico San Cecilio	Granada
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital de Guadalajara	Guadalajara
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital de Igualada	Igualada	Barcelona
Spain	Hospital de Jerez	Jerez de la Frontera	Cádiz
Spain	Hospital Universitario de Canarias	La Laguna	Tenerife
Spain	Hospital Universitario Severo Ochoa	Leganés	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hsopital Doce de Octubre	Madrid
Spain	MD Anderson	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Central Universitario de Asturias	Oviedo	Asturias
Spain	Hospital Son Llatzer	Palma de Mallorca	Baleares
Spain	Hospital Quirón	Pozuelo de Alarcón	Madrid
Spain	Hospital Serranía de Ronda	Ronda	Málaga
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital de Donostia	San Sebastián	Guipúzcoa
Spain	Hospital Universitario Nuestra Señora de la Candelaria	Santa Cruz de Tenerife	Tenerife
Spain	Hospital Nuestra Señora De Valme	Sevilla
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital La Fe	Valencia
Spain	Hospital Río Hortega	Valladolid
Spain	Hospital Provincial de Zamora	Zamora
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Asociación para el Progreso de la Oncología en Málaga	Roche Farma, S.A

Country where clinical trial is conducted

Spain,