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

Completed

• Conditions: HER-2 Positive Breast Cancer

• Registration Number: NCT01433926
• Lead Sponsor: Asociación para el Progreso de la Oncología en Málaga

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-03
• Status Verified: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-13
• Last Update Submitted: 2011-09-13
• Study First Posted: 2011-09-14
• Last Update Posted: 2011-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (39)

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Tenerife, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Central Universitario de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital de Igualada; 🇪🇸 Igualada, Barcelona, Spain

Hospital Punta de Europa; 🇪🇸 Algeciras, Cádiz, Spain

Hospital Príncipe de Asturias; 🇪🇸 Alcalá de Henares, Madrid, Spain

Hospital de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital de Donostia; 🇪🇸 San Sebastián, Guipúzcoa, Spain

Hospital Universitario Nuestra Señora de la Candelaria; 🇪🇸 Santa Cruz de Tenerife, Tenerife, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Hospital de Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Nuestra Señora De Valme; 🇪🇸 Sevilla, Spain

Hospital Río Hortega; 🇪🇸 Valladolid, Spain

Hospital Provincial de Zamora; 🇪🇸 Zamora, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Serranía de Ronda; 🇪🇸 Ronda, Málaga, Spain

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Clínico San Cecilio; 🇪🇸 Granada, Spain

Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital oncológico de Galicia; 🇪🇸 A Coruña, Spain

Hospital General Yagüe; 🇪🇸 Burgos, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hsopital Doce de Octubre; 🇪🇸 Madrid, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Quirón; 🇪🇸 Pozuelo de Alarcón, Madrid, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Hospital de Alcoy Virgen de los Lirios; 🇪🇸 Alcoy, Alicante, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Baleares, Spain

MD Anderson; 🇪🇸 Madrid, Spain

Hospital Clinic i Provincial; 🇪🇸 Barcelona, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital de Jerez; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Severo Ochoa; 🇪🇸 Leganés, Madrid, Spain