Clinical trial NCT01433926: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER-2 Positive Breast Cancer
Keywords: Breast cancer.
Trastuzumab.
Complete remission.
Lead sponsor: Asociación para el Progreso de la Oncología en Málaga
Sponsor class: OTHER
Collaborators: name: Roche Farma, S.A
First posted: 2011-09-14
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with disseminated breast cancer, HER-2 3+ or FISH+.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

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